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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01DK117843 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to examine whether adding phone coaching to an Internet-based weight loss program can improve weight loss outcomes at 4 months and 1 year. All individuals will receive a 4-month, Internet-delivered weight loss program followed by an 8-month Internet-delivered weight loss maintenance program. Some individuals will also be selected to receive either 3 weeks or 12 weeks of phone coaching. Assessments of weight, diet, physical activity, and psychosocial factors will occur at baseline, 4 months, and 1 year.
All individuals enrolled in this study will receive a 4-month Internet-based weight loss program followed by an 8-month Internet-based weight loss maintenance program. During the first 4 months, each week individuals will be asked to view a 10-15-minute multi-media lesson (one per week). These lessons focus on behavioral principles for changing diet and physical activity behaviors. Participants are also given weight loss, calorie intake, and physical activity goals. They are taught how to self-monitor this information and are instructed to submit it weekly on the study website. Automated, weekly individualized feedback is provided. Following the 4-month weight loss program participants will receive an 8-month weight loss maintenance program. During this time, they will be asked to view monthly video lessons which focus on strategies for successful WL maintenance and instructed to continue to self-monitor weight, calorie intake, and physical activity minutes on the study website for one week per month. Automated, monthly feedback is provided.
In addition to the Internet program described above, some individuals enrolled in this study will be selected to receive phone coaching. Those selected for 'brief' phone coaching will be asked to complete 3 phone calls with a coach between weeks 5-8 of the study and those selected to receive 'extended' phone coaching will be asked to complete 12 phone calls with a coach between weeks 5-16. The first coaching call will be approximately 45 minutes in duration and all subsequent calls will be approximately 15 minutes in duration. The coach will assist participants in developing a meal plan, problem solving around current barriers, and goal setting. Upon completion of all coaching calls participants will have no additional interaction with the coach, but will remain enrolled in the Internet program.
Assessments will occur at baseline, 4, and 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet weight loss + possibility of brief phone coaching | Experimental | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. |
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| Internet weight loss + possibility of extended phone coaching | Experimental | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. |
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| Internet weight loss only | Active Comparator | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based weight loss program | Behavioral | 12-month, Internet-based weight loss/maintenance program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Weight Change at 4 Months | Weight change was assessed using weight at baseline and 4 months | 4 months after start of weight loss program |
| Percent Weight Change at 12 Months | Weight change was assessed using weight at baseline and 12 months | 12 months after start of weight loss program |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Supplemental Coaching Per kg of Weight Loss | Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss | 12 months after start of weight loss program |
| Change in Physical Activity Minutes (Min/wk) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Unick, PhD | The Miriam Hospital's Weight Control and Diabetes Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miriam Hospital's Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38848067 | Derived | Unick JL, Pellegrini CA, Dunsiger SI, Demos KE, Thomas JG, Bond DS, Lee RH, Webster J, Wing RR. An Adaptive Telephone Coaching Intervention for Patients in an Online Weight Loss Program: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414587. doi: 10.1001/jamanetworkopen.2024.14587. |
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Study protocol, statistical analysis plan, and informed consent document can be found within this clinicaltrials.gov record. Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).
baseline to 12 months
Requests to view or utilize de-identified, participant-level data can be sent to the Principal Investigator (Dr. Jessica Unick - junick@lifespan.org).
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Randomization occurred at baseline, but participants were not informed of their randomization assignment until 1 month. Those reporting a 1-month weight then went on to receive brief coaching, extended coaching, or no coaching based upon randomization assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Internet Weight Loss + Possibility of Brief Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Brief phone coaching: Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| FG001 | Internet Weight Loss + Possibility of Extended Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Extended phone coaching: Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| FG002 | Internet Weight Loss Only | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
These data only include participants who reported a 1-month weight (n=437 out of 452 who began the weight loss program), given that those who did not report a 1-month weight were not eligible to receive coaching and did not continue with the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Internet Weight Loss + Possibility of Brief Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Brief phone coaching: Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| 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 | Percent Weight Change at 4 Months | Weight change was assessed using weight at baseline and 4 months | Reflects the number of participants in each treatment arm who completed the 4-month assessment | Posted | Mean | Standard Deviation | percent change | 4 months after start of weight loss program |
|
Adverse event data was collected over the entire 12-month intervention period
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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 | Internet Weight Loss + Possibility of Brief Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive a brief period (i.e., once/week for 3 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Brief phone coaching: Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | The Miriam Hospital | 401-793-8966 | junick@lifespan.org |
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| 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 | Apr 4, 2020 | Jan 5, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2019 | May 20, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Brief phone coaching | Behavioral | Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
|
| Extended phone coaching | Behavioral | Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
|
Physical activity was assessed via Actigraph accelerometers and included moderate-to-vigorous physical activity that was accumulated in bouts of >=10 minutes. A change score between baseline and 4 months was calculated.
| 4 months after study enrollment |
| Change in Dietary Intake (Kcals) | Dietary intake was assessed using self-reported kcal totals obtained from food diaries. The change was calculated from baseline to 4 months. | 4 months after start of weight loss program |
| Self-monitoring of Calorie Intake | Percentage of days that participant self-monitored their calorie intake on study website | 4 months after start of weight loss program |
| Video Lesson Viewing | Percentage of video lessons viewed on study website | 4 months after start of weight loss program |
| BG001 | Internet Weight Loss + Possibility of Extended Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Extended phone coaching: Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| BG002 | Internet Weight Loss Only | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participants who selected 'other' for race were coded as 'unknown or not reported' | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Internet Weight Loss + Possibility of Extended Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Extended phone coaching: Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. |
| OG002 | Internet Weight Loss Only | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. |
|
|
| Primary | Percent Weight Change at 12 Months | Weight change was assessed using weight at baseline and 12 months | Reflects the number of participants who completed the 12-month assessment | Posted | Mean | Standard Deviation | percent change | 12 months after start of weight loss program |
|
|
|
| Secondary | Cost of Supplemental Coaching Per kg of Weight Loss | Cost-effectiveness analyses were completed to determine the intervention cost per kg of weight loss | The cost of adding supplemental coaching to a pre-existing weight loss program was calculated per enrolled participant. Data was not collected in the "Internet Weight Loss Only" Arm for this outcome measure since these participants did not receive supplemental coaching. | Posted | Number | dollars per kilogram of weight loss | 12 months after start of weight loss program |
|
|
|
| Secondary | Change in Physical Activity Minutes (Min/wk) | Physical activity was assessed via Actigraph accelerometers and included moderate-to-vigorous physical activity that was accumulated in bouts of >=10 minutes. A change score between baseline and 4 months was calculated. | The participant flow data for this study was based upon whether or not weight (the primary outcome) was measured at each assessment period. Some participants completed a weight assessment at 4 months but either did not wear the physical activity monitor or did not wear the monitor for enough days (i.e., 4 or more days with greater than 8 hours of device wear time per day). Thus, the number of participants analyzed here is less than what was reported in the Participant Flow. | Posted | Mean | Standard Deviation | change in min/wk | 4 months after study enrollment |
|
|
|
| Secondary | Change in Dietary Intake (Kcals) | Dietary intake was assessed using self-reported kcal totals obtained from food diaries. The change was calculated from baseline to 4 months. | The participant flow data for this study was based upon whether or not weight (the primary outcome) was measured at each assessment period. Some participants completed a weight assessment at 4 months but did not complete a food diary at this time point. Thus, the number of participants analyzed here is less than what was reported in the Participant Flow. | Posted | Mean | Standard Deviation | change in kcals | 4 months after start of weight loss program |
|
|
|
| Secondary | Self-monitoring of Calorie Intake | Percentage of days that participant self-monitored their calorie intake on study website | Percentage of days that participants monitored their calorie intake on the study website over the first 4 months of the program (out of 112) | Posted | Mean | Standard Deviation | % of days | 4 months after start of weight loss program |
|
|
|
| Secondary | Video Lesson Viewing | Percentage of video lessons viewed on study website | Percentage of weekly video lessons that participants viewed over the first 4 months of the program (out of 16) | Posted | Mean | Standard Deviation | % of lessons | 4 months after start of weight loss program |
|
|
|
| 0 |
| 143 |
| 0 |
| 143 |
| 0 |
| 143 |
| EG001 | Internet Weight Loss + Possibility of Extended Phone Coaching | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. Some participants in this group will also be selected to receive an extended period (i.e., once/week for 12 weeks) of phone coaching starting at week 5. The first coaching call will be approximately 45 minutes in duration and remaining calls with be 10-15 minutes. Coaches will problem solve with participants and help them develop an individualized meal plan. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. Extended phone coaching: Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach. | 0 | 148 | 0 | 148 | 0 | 148 |
| EG002 | Internet Weight Loss Only | Participants randomized to this group will receive a 4-month, Internet-delivered weight loss program followed by an 8-month, Internet-delivered weight loss maintenance program. All individuals will be taught behavioral strategies for changing diet and physical activity behaviors via video lessons. No participants in this group will receive any phone coaching. Internet-based weight loss program: 12-month, Internet-based weight loss/maintenance program. | 0 | 146 | 0 | 146 | 0 | 146 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |