Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K07CA196840 | U.S. NIH Grant/Contract | View source | |
| R21CA219028-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Condition #1 | Experimental | core, support calls |
|
| Experimental Condition #2 | Experimental | core, support calls, app+ |
|
| Experimental Condition #3 | Experimental | core, support calls, buddy |
|
| Experimental Condition #4 | Experimental | core, support calls, online gym |
|
| Experimental Condition #5 | Experimental | core, support calls, app notifications |
|
| Experimental Condition #6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Core | Behavioral | The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to a 12 Week Technology Supported Physical Activity Intervention | Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12. | 12 weeks |
| Participant Retention | Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100]. | 12 weeks |
| Intervention Reach | Percentage of individuals randomized of those who were sent a study screening survey | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-Women will be excluded if they report any of the following:
ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40795071 | Derived | Solk P, Song J, Reading J, Starikovsky J, Cullather E, Wang S, Hasanaj K, Morelli WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Frey J, Phillips SM. Feasibility and acceptability of the Fit2Thrive mHealth physical activity promotion intervention components in breast cancer survivors. Transl Behav Med. 2025 Jan 16;15(1):ibaf033. doi: 10.1093/tbm/ibaf033. | |
| 37203237 | Derived | Solk P, Song J, Welch WA, Spring B, Cella D, Penedo F, Ackermann R, Courneya KS, Siddique J, Freeman H, Starikovsky J, Mishory A, Alexander J, Wolter M, Carden L, Phillips SM. Effect of the Fit2Thrive Intervention on Patient-reported Outcomes in Breast Cancer Survivors: A Randomized Full Factorial Trial. Ann Behav Med. 2023 Aug 21;57(9):765-776. doi: 10.1093/abm/kaad024. |
Not provided
Not provided
Data collected in this study will be made available to other researchers in compliance with the NIH Data Sharing Policy.
Not provided
Not provided
Not provided
Not provided
A total of 280 women signed informed consent and enrolled in the study. However, in order to be randomized, participants must complete all baseline assessments. This includes wearing the accelerometer for a minimum of 5 valid days and completing all online questionnaires. A total of 269 women met the criteria for randomization.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Condition #1 | core, support calls Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. |
| FG001 | Experimental Condition #2 | core, support calls, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. |
| FG002 | Experimental Condition #3 | core, support calls, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG003 | Experimental Condition #4 | core, support calls, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. |
| FG004 | Experimental Condition #5 | core, support calls, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications |
| FG005 | Experimental Condition #6 | core, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. |
| FG006 | Experimental Condition #7 | core, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG007 | Experimental Condition #8 | core, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. |
| FG008 | Experimental Condition #9 | core, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications |
| FG009 | Experimental Condition #10 | core, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG010 | Experimental Condition #11 | core, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG011 | Experimental Condition #12 | core, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG012 | Experimental Condition #13 | core, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. |
| FG013 | Experimental Condition #14 | core, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| FG014 | Experimental Condition #15 | core, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications |
| FG015 | Experimental Condition #16 | core, support calls, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG016 | Experimental Condition #17 | core, support calls, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. |
| FG017 | Experimental Condition #18 | core, support calls, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications |
| FG018 | Experimental Condition #19 | core, support calls, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG019 | Experimental Condition #20 | core, support calls, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG020 | Experimental Condition #21 | core, support calls, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| FG021 | Experimental Condition #22 | core, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG022 | Experimental Condition #23 | core, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG023 | Experimental Condition #24 | core, support calls, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG024 | Experimental Condition #25 | core, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG025 | Experimental Condition #26 | core, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| FG026 | Experimental Condition #27 | core, support calls, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG027 | Experimental Condition #28 | core, support calls, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG028 | Experimental Condition #29 | core, support calls, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| FG029 | Experimental Condition #30 | core Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. |
| FG030 | Experimental Condition #31 | core, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| FG031 | Experimental Condition #32 | core, support calls, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All individuals who were randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Condition #1 | core, support calls Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. |
| BG001 | Experimental Condition #2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to a 12 Week Technology Supported Physical Activity Intervention | Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12. | All participants randomized. | Posted | Mean | Standard Deviation | Percentage of Days Fitbit Worn | 12 weeks |
|
|
Adverse events were collected for the duration of the 24 week study period.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Condition #1 | core, support calls Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Siobhan Phillips | Northwestern University | 312-503-4235 | smphillips@northwestern.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2018 | Dec 14, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000682 | Amyloid |
| ID | Term |
|---|---|
| D046912 | Multiprotein Complexes |
| D046911 | Macromolecular Substances |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
core, app+ |
|
| Experimental Condition #7 | Experimental | core, app+, buddy |
|
| Experimental Condition #8 | Experimental | core, app+, online gym |
|
| Experimental Condition #9 | Experimental | core, app+, app notifications |
|
| Experimental Condition #10 | Experimental | core, buddy |
|
| Experimental Condition #11 | Experimental | core, buddy, online gym |
|
| Experimental Condition #12 | Experimental | core, buddy, app notifications |
|
| Experimental Condition #13 | Experimental | core, online gym |
|
| Experimental Condition #14 | Experimental | core, online gym, app notifications |
|
| Experimental Condition #15 | Experimental | core, app notifications |
|
| Experimental Condition #16 | Experimental | core, support calls, app+, buddy |
|
| Experimental Condition #17 | Experimental | core, support calls, app+, online gym |
|
| Experimental Condition #18 | Experimental | core, support calls, app+, app notifications |
|
| Experimental Condition #19 | Experimental | core, support calls, buddy, online gym |
|
| Experimental Condition #20 | Experimental | core, support calls, buddy, app notifications |
|
| Experimental Condition #21 | Experimental | core, support calls, online gym, app notifications |
|
| Experimental Condition #22 | Experimental | core, app+, buddy, online gym |
|
| Experimental Condition #23 | Experimental | core, app+, buddy, online gym, app notifications |
|
| Experimental Condition #24 | Experimental | core, support calls, buddy, online gym, app notifications |
|
| Experimental Condition #25 | Experimental | core, buddy, online gym, app notifications |
|
| Experimental Condition #26 | Experimental | core, app+, online gym, app notifications |
|
| Experimental Condition #27 | Experimental | core, support calls, app+, buddy, online gym |
|
| Experimental Condition #28 | Experimental | core, support calls, app+, buddy, app notifications |
|
| Experimental Condition #29 | Experimental | core, support calls, app+, online gym, app notifications |
|
| Experimental Condition #30 | Experimental | core |
|
| Experimental Condition #31 | Experimental | core, app+, buddy, app notifications |
|
| Experimental Condition #32 | Experimental | core, support calls, app+, buddy, online gym, app notifications |
|
| Support Calls | Behavioral | Participants will receive 6 bi-weekly phone calls from study staff. |
|
| App+ | Behavioral | Participants will receive "deluxe" version of smartphone app with additional features. |
|
| Online gym | Behavioral | Participants will receive access to online exercise videos. |
|
| App notifications | Behavioral | Participants will receive motivational app notifications |
|
| Buddy | Behavioral | Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
|
| Change from baseline to 12 weeks |
| Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). | Change from baseline to 24 weeks |
| Change in Fatigue From Before to After a 12-Week Intervention | Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | Change from baseline to 12 weeks |
| Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | Change from baseline to 24 weeks |
| Change in Physical Function From Before to After a 12-Week Intervention | Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | Change from baseline to 12 weeks |
| Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off. | Change from baseline to 24 weeks |
| Change in Depression From Before to After a 12-Week Intervention | Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | Change from baseline to 12 weeks |
| Change in Depression From Pre-Intervention to 24-week Follow-up | Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | Change from baseline to 24 weeks |
| Adherence to During the Full 24-Week Study Period | Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24. | 24 weeks |
| Participant Retention at 24 Week Follow-up | Percentage of participants retained at 24 weeks of those randomized | 24 weeks |
| Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol. | Change from baseline to 12 weeks |
| Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. | Change from baseline to 24 weeks |
| Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. | Change from baseline to 12 weeks |
| Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects. | Change from baseline to 24 weeks |
| Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better. | Change from baseline to 12 weeks |
| Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better. | Change from baseline to 24 weeks |
| Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better. | Change from baseline to 12 weeks |
| Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better. | Change from baseline to 24 weeks |
| Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | Change from baseline to 12 weeks |
| Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better. | Change from baseline to 24 weeks |
| Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | Change from baseline to 12 weeks |
| Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | Change from baseline to 24 weeks |
| Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | Change from baseline to 12 weeks |
| Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | Change from baseline to 24 weeks |
| Lost to Follow-up |
|
| Death |
|
core, support calls, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. |
| BG002 | Experimental Condition #3 | core, support calls, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG003 | Experimental Condition #4 | core, support calls, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. |
| BG004 | Experimental Condition #5 | core, support calls, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications |
| BG005 | Experimental Condition #6 | core, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. |
| BG006 | Experimental Condition #7 | core, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG007 | Experimental Condition #8 | core, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. |
| BG008 | Experimental Condition #9 | core, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications |
| BG009 | Experimental Condition #10 | core, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG010 | Experimental Condition #11 | core, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG011 | Experimental Condition #12 | core, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG012 | Experimental Condition #13 | core, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. |
| BG013 | Experimental Condition #14 | core, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| BG014 | Experimental Condition #15 | core, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications |
| BG015 | Experimental Condition #16 | core, support calls, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG016 | Experimental Condition #17 | core, support calls, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. |
| BG017 | Experimental Condition #18 | core, support calls, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications |
| BG018 | Experimental Condition #19 | core, support calls, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG019 | Experimental Condition #20 | core, support calls, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG020 | Experimental Condition #21 | core, support calls, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| BG021 | Experimental Condition #22 | core, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG022 | Experimental Condition #23 | core, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG023 | Experimental Condition #24 | core, support calls, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG024 | Experimental Condition #25 | core, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG025 | Experimental Condition #26 | core, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| BG026 | Experimental Condition #27 | core, support calls, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG027 | Experimental Condition #28 | core, support calls, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG028 | Experimental Condition #29 | core, support calls, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications |
| BG029 | Experimental Condition #30 | core Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. |
| BG030 | Experimental Condition #31 | core, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG031 | Experimental Condition #32 | core, support calls, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. |
| BG032 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants Randomized | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Participant Retention | Percentage of participants retained at the end of the 12 week intervention of those randomized [(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized*100]. | Posted | Number | Percentage of participants retained | 12 weeks |
|
|
|
| Primary | Intervention Reach | Percentage of individuals randomized of those who were sent a study screening survey | Posted | Number | Percentage of participants randomized | Baseline |
|
|
|
| Secondary | Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention | Physical activity will be measured at baseline and at 12 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). | One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | Minutes per week | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up | Physical activity will be measured at baseline and at 24 weeks. The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). | One participant was excluded because data values were deemed implausible. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | Minutes per week | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Fatigue From Before to After a 12-Week Intervention | Fatigue is measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Fatigue From Pre-Intervention to 24-Week Follow-up | Fatigue will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue 8a health measure. T-scores range from 33.1 to 77.8 Higher scores indicate more fatigue. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Physical Function From Before to After a 12-Week Intervention | Physical function will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 12 weeks |
|
|
|
| Secondary | Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up | Physical function will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-physical function 20a health measure. T-scores range from 32.7 to 62.7. Higher scores indicate better physical functioning. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. The treatment effect is calculated as the mean difference in the change in physical function between baseline and 24-weeks for each component on versus off. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Depression From Before to After a 12-Week Intervention | Depression will be measured at baseline and 12 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Depression From Pre-Intervention to 24-week Follow-up | Depression will be measured at baseline and 24 weeks using the Patient Reported Outcomes Measurement Information System (PROMIS)-Depression 8a health measure. T-scores range from 38.2 to 81.3. Higher scores indicate more depression. T-score metric with a mean of 50 and standard deviation of 10 in the U.S. general population. | All participants randomized. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | t-score on a scale | Change from baseline to 24 weeks |
|
|
|
| Secondary | Adherence to During the Full 24-Week Study Period | Adherence during the 24-week study period will be monitored continuously using study app. This measure the average percentage of days each randomized participant wore the Fitbit from weeks 1 to 24. | All randomized participants. | Posted | Mean | Standard Deviation | Percentage of days the Fitbit was worn | 24 weeks |
|
|
|
| Secondary | Participant Retention at 24 Week Follow-up | Percentage of participants retained at 24 weeks of those randomized | All participants randomized | Posted | Number | Percentage of participants retained | 24 weeks |
|
|
|
| Secondary | Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional) | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminescent immunoassay protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional) | Interleukin-6 (IL-6) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-6.In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional) | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional) | Interleukin-10 (IL-10) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Higher IL-10 may have protective effects. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for IL-10. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional) | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. Lower values are better. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional) | tumor necrosis factor-alpha (TNFα) will be self-collected via finger prick to obtain dried blood spot and will be quantified using a standard multiplex electrochemiluminscent immunoassay protocol. TLower values are better. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for TNFα. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | pg/mL | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional) | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using ELISA. Lower values are better. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/L | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional) | C-reactive protein (CRP) will be self-collected via finger prick to obtain dried blood spot and will be quantified using standard ELISA. Lower values are better. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for CRP. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/L | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Triglycerides From Before to After a 12 Week Intervention (Optional) | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional) | Triglycerides are self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. Lower values are better. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for triglycerides. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in Blood Glucose From Before to After a 12 Week Intervention (Optional) | Blood glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional) | Blood Glucose is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for blood glucose. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 24 weeks |
|
|
|
| Secondary | Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional) | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 12 weeks |
|
|
|
| Secondary | Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional) | High density lipoprotein cholesterol (HDL) is self-collected via finger prick to obtain a dried blood spot and quantified using a standard coupled enzymatic protocol. | This includes all participants who agreed to participate in dried blood spots and had at least one valid sample for HDL. In a full factorial trial, participants are randomized to receive each intervention component (support calls, buddy, app notifications, online gym, app+) "on" or "off." Participants randomized to "on" are compared to those randomized to "off." All participants get the core intervention so there is no comparison group. | Posted | Mean | Standard Error | mg/dL | Change from baseline to 24 weeks |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Experimental Condition #2 | core, support calls, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. | 0 | 9 | 0 | 9 | 3 | 9 |
| EG002 | Experimental Condition #3 | core, support calls, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG003 | Experimental Condition #4 | core, support calls, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG004 | Experimental Condition #5 | core, support calls, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Experimental Condition #6 | core, app+ Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. | 1 | 9 | 0 | 9 | 1 | 9 |
| EG006 | Experimental Condition #7 | core, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG007 | Experimental Condition #8 | core, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG008 | Experimental Condition #9 | core, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications | 0 | 9 | 0 | 9 | 2 | 9 |
| EG009 | Experimental Condition #10 | core, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG010 | Experimental Condition #11 | core, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG011 | Experimental Condition #12 | core, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 1 | 8 |
| EG012 | Experimental Condition #13 | core, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG013 | Experimental Condition #14 | core, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications | 0 | 8 | 0 | 8 | 1 | 8 |
| EG014 | Experimental Condition #15 | core, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App notifications: Participants will receive motivational app notifications | 0 | 8 | 0 | 8 | 0 | 8 |
| EG015 | Experimental Condition #16 | core, support calls, app+, buddy Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG016 | Experimental Condition #17 | core, support calls, app+, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG017 | Experimental Condition #18 | core, support calls, app+, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications | 0 | 8 | 0 | 8 | 0 | 8 |
| EG018 | Experimental Condition #19 | core, support calls, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG019 | Experimental Condition #20 | core, support calls, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG020 | Experimental Condition #21 | core, support calls, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications | 0 | 8 | 0 | 8 | 0 | 8 |
| EG021 | Experimental Condition #22 | core, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG022 | Experimental Condition #23 | core, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG023 | Experimental Condition #24 | core, support calls, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG024 | Experimental Condition #25 | core, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG025 | Experimental Condition #26 | core, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications | 1 | 8 | 0 | 8 | 1 | 8 |
| EG026 | Experimental Condition #27 | core, support calls, app+, buddy, online gym Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG027 | Experimental Condition #28 | core, support calls, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG028 | Experimental Condition #29 | core, support calls, app+, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications | 0 | 8 | 0 | 8 | 0 | 8 |
| EG029 | Experimental Condition #30 | core Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG030 | Experimental Condition #31 | core, app+, buddy, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. App+: Participants will receive "deluxe" version of smartphone app with additional features. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 9 | 0 | 9 | 1 | 9 |
| EG031 | Experimental Condition #32 | core, support calls, app+, buddy, online gym, app notifications Core: The core intervention will include educational materials, access to a basic smartphone app and a Fitbit. Support Calls: Participants will receive 6 bi-weekly phone calls from study staff. App+: Participants will receive "deluxe" version of smartphone app with additional features. Online gym: Participants will receive access to online exercise videos. App notifications: Participants will receive motivational app notifications Buddy: Participants will choose a buddy to receive a Fitbit and support them during the intervention. | 0 | 8 | 0 | 8 | 2 | 8 |
| Torn/Pulled Muscle | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Tendinitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Multiple Sclerosis Relapse | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | Systematic Assessment |
|
| Breast reconstruction surgery | Surgical and medical procedures | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Dizziness Spell | General disorders | Systematic Assessment |
|
| Concussion | Nervous system disorders | Systematic Assessment |
|
| Dehydration | General disorders | Systematic Assessment |
|
| Cancer Metastasis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Sprain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
Not provided
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|
|
| "Off" Group Change |
|
|