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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL136979 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Massachusetts, Worcester | OTHER |
| Worcester Polytechnic Institute | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of the project is to conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook versus via in-person group sessions. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. If efficacious and cost-effective, the Facebook-delivered intervention leads naturally to strategies for scaling up for widespread impact.
Post-partum weight retention contributes to obesity for many women, increasing risk for cardiovascular disease and other chronic diseases and complicating future pregnancies. Lifestyle interventions have shown to be modestly efficacious for post-partum weight loss in randomized controlled trials, yet interventions with numerous visits are logistically challenging for many post-partum women. Innovative and efficacious treatment models for post-partum weight loss that fit into the busy lives of new moms are needed, and cost-effectiveness is critical for adoption. Facebook may be an efficient platform for delivering evidence-based weight loss programming to post-partum women. Delivering interventions via Facebook allows us to connect with post-partum women where they are, more fully integrating into their lives and daily routines. Investigators have developed a post-partum weight loss intervention based on the Diabetes Prevention Program, tailored to needs of post-partum women and for delivery via Facebook. Investigators will conduct a feasibility pilot randomized trial comparing delivery of a post-partum weight loss intervention via Facebook to in-person group sessions. Primary outcomes are the feasibility of recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures in both treatment conditions. Weight loss will be described as an exploratory outcome. The project will provide preliminary data needed to finalize the design of a large randomized trial to compare the non-inferiority and cost-effectiveness of the post-partum weight loss intervention delivered via Facebook versus in-person group sessions. Demonstrating cost-effectiveness in addition to efficacy of our Facebook-delivered post-partum weight loss intervention is critical to support widespread implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Comparator | Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via a private ("secret") Facebook group. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. A study counselor will facilitate discussions about the topics posted in the Facebook group. Each participant will get an individualized calorie and physical activity goal to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Participants will also be encouraged to download the MyFitnessPal app to track daily diet. |
| |
| Traditional | Active Comparator | Women will receive the Healthy Moms intervention, a 6-month behavioral weight loss intervention, via in-person 90-minute group sessions (weekly in months 1-4, every other week in months 5-6). The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based lifestyle intervention. Intervention components will be introduced in the format of handouts, group discussions, and lists of existing resources. Each participant will get an individualized calorie and physical activity goal to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy Moms | Behavioral | The 6-month intervention will include dietary and exercise counseling and tips to help participants meet their healthy lifestyle goals. Participants will receive personalized calorie and physical activity goals to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Counselors will encourage and support participants to make a plan for incorporating regular physical activity into their lives in a way (i.e., duration per session, frequency per week) that works for that individual woman. We will encourage participants to track their diet and exercise daily. We will encourage participants to use My Fitness Pal to track their diet and activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment | Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized. | Baseline |
| Sustained Participation | We will calculate sustained participation as time to last intervention session attended in the in-person condition and as time to last post, comment, or reaction (based on date of last post or comment reacted to) in the Facebook condition. | 6 months |
| Contamination | Participants in both treatment conditions will report if they have participated in other weight loss programs (online or in-person), and whether they have searched for weight loss support on Facebook or other online social networks. | 6 months |
| Retention | Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition. | 6 months |
| Retention | Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition. | 12 months |
| Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at baseline. | Baseline |
| Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change (Exploratory) | Weight will be measured at baseline and 6 months. Percent weight change will be calculated. | 6 months |
| Weight Change (Exploratory) | Weight will be measured at baseline and 12 months. Percent weight change will be calculated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Molly E. Waring, PhD | University of Connecticut | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31778116 | Background | Waring ME, Libby BA, Moore Simas TA, Bracken ML, Bibeau JL, Herrera V, Wang J, Pagoto SL. Delivering a Post-Partum Weight Loss Intervention via Facebook or In-Person Groups: Protocol for a Randomized Feasibility Pilot Trial. JMIR Res Protoc. 2019 Nov 28;8(11):e15530. doi: 10.2196/15530. | |
| 37103991 | Derived | Waring ME, Pagoto SL, Moore Simas TA, Blackman Carr LT, Eamiello ML, Libby BA, Rudin LR, Heersping GE. Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial. JMIR Mhealth Uhealth. 2023 Apr 27;11:e41545. doi: 10.2196/41545. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 6-month post-partum weight loss intervention delivered via a private Facebook group | |
| FG001 | Traditional | 6-month post-partum weight loss intervention delivered via in-person group meetings |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 6-month post-partum weight loss intervention delivered via a private Facebook group | |
| BG001 | Traditional | 6-month post-partum weight loss intervention delivered via in-person group meetings |
| 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 | Recruitment | Recruitment rates will be calculated from the number of patients approached, screened, consented, and randomized. | Posted | Count of Participants | Participants | Baseline |
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Adverse events were collected during the intervention and at 6-month and 12-month follow-up assessments
Adverse events were spontaneous reported by participants during the intervention and at follow-up assessments. Depressive symptoms and pregnancy were queried at the 6-month and 12-month assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 6-month behavioral weight loss intervention delivered via a private Facebook group |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Communicable disease (e.g., cold, flu) | General disorders | Non-systematic Assessment |
In wave 2, due to safety concerns related to COVID-19, the last two intervention meetings for the Traditional condition were held via WebEx (vs in-person meetings) and 6-month and 12-month assessments for participants in both conditions were held remotely (vs in-person study visits). Thus in wave 2, all follow-up weights are self-reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Molly Waring | University of Connecticut | 860-486-1446 | molly.waring@uconn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2020 | Oct 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 20, 2021 | Oct 21, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2018 | Oct 21, 2021 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 6 months |
| Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at 12 months. | 12 months |
| 12 months |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | greater Hartford, CT region | Number | participants |
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| Weight | Weight measured at baseline (pounds) | Median | Inter-Quartile Range | pounds |
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|
| Primary | Sustained Participation | We will calculate sustained participation as time to last intervention session attended in the in-person condition and as time to last post, comment, or reaction (based on date of last post or comment reacted to) in the Facebook condition. | Latest treatment module participated in based on last intervention meeting attended (Traditional) or last treatment module engaged in based on original posts, replies/comments, reactions, and poll votes (Facebook) | Posted | Median | Inter-Quartile Range | latest treatment module participated in | 6 months |
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| Primary | Contamination | Participants in both treatment conditions will report if they have participated in other weight loss programs (online or in-person), and whether they have searched for weight loss support on Facebook or other online social networks. | Participants reported use of other weight loss programs and seeking weight loss info/support on social media on the 6-month survey. We report the number and percentage of participants in each condition that reported use of other weight loss programs, sought weight loss info/support on social media, both, or neither. These data are available only for participants who completed the 6-month survey. Note that we encouraged participants in both groups to reference online resources (e.g., recipes). | Posted | Count of Participants | Participants | 6 months |
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| Primary | Retention | Retention is calculated as the percentage of participants who complete the 6-month follow-up study assessment in each condition. | Retention is defined as completing 6-month follow-up study assessment (providing weight and/or completing the follow-up survey) | Posted | Count of Participants | Participants | 6 months |
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| Primary | Retention | Retention is calculated as the percentage of participants who complete the 12-month follow-up study assessment in each condition. | Retention is defined as completing 12-month follow-up study assessment (providing weight and/or completing the follow-up survey) | Posted | Count of Participants | Participants | 12 months |
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| Primary | Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at baseline. | Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Primary | Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at 6 months. | Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 6-month survey, participants who did not complete the survey are missing this measure. | Posted | Count of Participants | Participants | 6 months |
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|
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| Primary | Degree of Missingness in Study Measures | Percent of participants missing data on each measure/item included in data collection at 12 months. | Missing (or incomplete) measures needed for cost-effectiveness aim of subsequent efficacy trial: weight and/or quality of life measure. Note that as quality of measure was assessed as part of 12-month survey, participants who did not complete the survey are missing this measure. | Posted | Count of Participants | Participants | 12 months |
|
|
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| Secondary | Weight Change (Exploratory) | Weight will be measured at baseline and 6 months. Percent weight change will be calculated. | Percent weight change from baseline to 6 months. All baseline weights were measured at a study visit. At 6 months, weight was measured at a study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported. | Posted | Mean | Standard Deviation | percent weight loss from baseline | 6 months |
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| Secondary | Weight Change (Exploratory) | Weight will be measured at baseline and 12 months. Percent weight change will be calculated. | Percent weight change from baseline to 12 months. All baseline weights were measured at study visit. At 12 months, weight was measured at study visit or participants self-reported current or pre-pregnancy weight (if pregnant). Note that due to COVID19, all follow-up weights for wave 2 were self-reported. Complete case weight change is reported. | Posted | Mean | Standard Deviation | percent weight loss from baseline | 12 months |
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 25 |
| 30 |
| EG001 | Traditional | 6-month behavioral weight loss intervention delivered via in-person group meetings | 0 | 32 | 0 | 32 | 23 | 32 |
| 5% or greater weight gain | General disorders | Non-systematic Assessment |
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| Musculoskeletal pain or injury (not related to exercise) | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pregnancy during intervention or follow-up | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Depressive symptoms | Psychiatric disorders | Non-systematic Assessment |
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| D001519 | Behavior |
| Sought weight loss info or support on social media |
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| Neither |
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| Available information on both weight and quality of life |
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| Available information for both weight and quality of life |
|