Weight Loss
Conditions
Brief summary
The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.
Detailed description
The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).
Interventions
BEHAVIORAL12 Telephone Coaching Sessions
Participants will receive 12 telephone coaching sessions
BEHAVIORAL24 Telephone Coaching Sessions
Participants will receive 24 telephone coaching sessions
BEHAVIORALReport to Primary Care Physician
Participants will have a report detailing their weight loss progress sent to their primary care physician
BEHAVIORALText Messages
Participants will receive regular text messages
BEHAVIORALRecommendations to use meal replacements
Participants will receive recommendations from their coach to use meal replacements
BEHAVIORALBuddy Training
Participants will have a buddy that will be trained via webinars to be a supportive buddy
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Penn State University
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 and 60 years old * BMI 25-40 kg/m2 * Weight stable (no loss or gain \>25 lbs for the past 6 months) * Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight. * Own a Smartphone and be willing to install the Opt-IN app * Able to use the app to record dietary intake and weight onto the Smartphone Buddy participants must: * 18 years of age or older * Have access to a computer and internet * Be willing to undergo Buddy Training and participate in 4 webinars * Be willing to provide support and encouragement to the participant
Exclusion criteria
* Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months) * History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP) * Use an assistive device for mobility (e.g., wheelchair, walker, cane) * Plantar fasciitis * Hospitalization for a psychiatric disorder within the past 5 years * At risk for adverse cardiovascular (CVD) events with moderate intensity activity * Cannot read the study questionnaires * Committed to following an incompatible dietary regimen * Not be pregnant, trying to get pregnant, or lactating * Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation * Low motivation to change * Cannot live with a current or past Opt-IN participant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Change (kg) From Baseline to Month 6, Main Effect of Time | From Baseline to Month 6 | Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). |
| Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | From Baseline to Month 6 | Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention for <$500 | 6 months | Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-Regulation | 6 months | Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire |
| Treatment Adherence | 6 months | Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24) |
| Facilitation | 6 months | Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory |
| Supportive Accountability | 6 months | Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support |
| Self-monitoring Adherence | 6 months | Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity |
| Self-efficacy | 6 months | Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity |
Countries
United States
Participant flow
Recruitment details
8593 were screened. 1159 attended orientation. 1078 signed consent. 562 were randomized.
Pre-assignment details
Participants who signed an informed consent were invited to attend a baseline assessment where they were screened further for entry and exclusion criteria. Baseline data was gathered. Participants who continued to be eligible were scheduled for the randomization session where they learned their study assignment.
Participants by arm
| Arm | Count |
|---|---|
| 1. 12 Calls, PCP Participants received biweekly (12) coaching calls, and PCP Reports | 18 |
| 2. 12 Calls, PCP, MR, Buddy Participants received biweekly (12) coaching calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training. | 18 |
| 3. 12 Calls, PCP, Texts, Buddy Participants received 12 calls, PCP Reports, Texts, and Buddy Training | 18 |
| 4. 12 Calls, PCP, Texts, MR Participants received 12 calls, PCP Reports, Texts, and Meal Replacement Recommendations | 18 |
| 5. 12 Calls, Buddy Participants received 12 calls, and Buddy Training | 18 |
| 6. 12 Calls, MR Participants received 12 calls, and Meal Replacement Recommendations | 18 |
| 7. 12 Calls, Texts Participants received 12 calls, and Texts | 18 |
| 8. 12 Calls, Texts, MR, Buddy Participants received 12 calls, Texts, Meal Replacement Recommendations, and Buddy Training | 18 |
| 9. 24 Calls, PCP Participants received 24 calls, and PCP Reports | 19 |
| 10. 24 Calls, PCP, MR, Buddy Participants received 24 calls, PCP Reports, Meal Replacement Recommendations, and Buddy Training | 18 |
| 11. 24 Calls, PCP, Texts, Buddy Participants received 24 calls, PCP Reports, Texts, and Buddy Training | 18 |
| 12. 24 Calls, PCP, Texts, MR Participants received 24 calls, PCP Reports, Texts, and Meal Replacement Recommendations | 18 |
| 13. 24 Calls, Buddy Participants received 24 calls, and Buddy Training | 18 |
| 14. 24 Calls, MR Participants received 24 calls, and Meal Replacement Recommendations | 18 |
| 15. 24 Calls, Texts Participants received 24 calls, and Texts | 18 |
| 16. 24 Calls, Texts, MR, Buddy Participants received 24 calls, Texts, Meal Replacement Recommendations, and Buddy Training | 18 |
| 17. 12 Calls Participants received 12 calls | 17 |
| 18. 12 Calls, MR, Buddy Participants received 12 calls, Meal Replacement Recommendations, and Buddy Training | 18 |
| 19. 12 Calls, Texts, Buddy Participants received 12 calls, Texts, and Buddy Training | 17 |
| 20. 12 Calls, Texts, MR Participants received 12 calls, Texts, Meal Replacement Recommendations | 16 |
| 21. 12 Calls, PCP, Buddy Participants received 12 calls, PCP Reports, and Buddy Training | 16 |
| 22. 12 Calls, PCP, MR Participants received 12 calls, PCP Reports, and Meal Replacement Recommendations | 17 |
| 23. 12 Calls PCP, Texts Participants received 12 calls, PCP Reports, and Texts | 17 |
| 24. 12 Calls, PCP, Texts, MR, Buddy Participants received 12 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training | 18 |
| 25. 24 Calls Participants received 24 calls | 17 |
| 26. 24 Calls, MR, Buddy Participants received 24 calls, Meal Replacement Recommendations, and Buddy Training | 16 |
| 27. 24 Calls, Texts, Buddy Participants received 24 calls, Texts, and Buddy Training | 18 |
| 28. 24 Calls, Texts, MR Participants received 24 calls, Texts, and Meal Replacement Recommendations | 17 |
| 29. 24 Calls, PCP, Buddy Participants received 24 calls, PCP Reports, and Buddy Training | 18 |
| 30. 24 Calls, PCP, MR Participants received 24 calls, PCP Reports, and Meal Replacement Recommendations | 17 |
| 31. 24 Calls, PCP, Texts Participants received 24 calls, PCP Reports, and Texts | 17 |
| 32. 24 Calls, PCP, Texts, MR, Buddy Participants received 24 calls, PCP Reports, Texts, Meal Replacement Recommendations, and Buddy Training | 17 |
| Total | 562 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 | FG022 | FG023 | FG024 | FG025 | FG026 | FG027 | FG028 | FG029 | FG030 | FG031 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 2 | 0 | 2 | 3 | 3 | 1 | 2 | 3 | 1 | 2 | 2 | 1 | 2 | 1 | 3 | 1 | 3 | 3 | 2 | 1 | 3 | 1 | 4 | 1 | 1 | 2 | 3 | 3 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 1 | 0 | 2 | 3 | 1 | 0 | 1 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 2 | 1 | 1 | 2 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | 32. 24 Calls, PCP, Texts, MR, Buddy | 31. 24 Calls, PCP, Texts | 30. 24 Calls, PCP, MR | 29. 24 Calls, PCP, Buddy | 28. 24 Calls, Texts, MR | 27. 24 Calls, Texts, Buddy | 26. 24 Calls, MR, Buddy | 25. 24 Calls | 24. 12 Calls, PCP, Texts, MR, Buddy | 23. 12 Calls PCP, Texts | 22. 12 Calls, PCP, MR | 21. 12 Calls, PCP, Buddy | 20. 12 Calls, Texts, MR | 19. 12 Calls, Texts, Buddy | 18. 12 Calls, MR, Buddy | 17. 12 Calls | 16. 24 Calls, Texts, MR, Buddy | 15. 24 Calls, Texts | 14. 24 Calls, MR | 13. 24 Calls, Buddy | 12. 24 Calls, PCP, Texts, MR | 11. 24 Calls, PCP, Texts, Buddy | 10. 24 Calls, PCP, MR, Buddy | 9. 24 Calls, PCP | 8. 12 Calls, Texts, MR, Buddy | 7. 12 Calls, Texts | 6. 12 Calls, MR | 5. 12 Calls, Buddy | 4. 12 Calls, PCP, Texts, MR | 3. 12 Calls, PCP, Texts, Buddy | 2. 12 Calls, PCP, MR, Buddy | 1. 12 Calls, PCP |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.9 years STANDARD_DEVIATION 10.9 | 39.9 years STANDARD_DEVIATION 12 | 40.6 years STANDARD_DEVIATION 12.8 | 37.2 years STANDARD_DEVIATION 9.9 | 39.1 years STANDARD_DEVIATION 11.7 | 41.0 years STANDARD_DEVIATION 10.1 | 35.1 years STANDARD_DEVIATION 9 | 47.3 years STANDARD_DEVIATION 10.2 | 35.7 years STANDARD_DEVIATION 9.6 | 37.9 years STANDARD_DEVIATION 12.8 | 40.1 years STANDARD_DEVIATION 11.6 | 40.3 years STANDARD_DEVIATION 10.8 | 36.7 years STANDARD_DEVIATION 6 | 32.2 years STANDARD_DEVIATION 7.1 | 37.4 years STANDARD_DEVIATION 10.9 | 39.2 years STANDARD_DEVIATION 10.5 | 38.2 years STANDARD_DEVIATION 12 | 35.8 years STANDARD_DEVIATION 11.8 | 39.8 years STANDARD_DEVIATION 12.8 | 36.3 years STANDARD_DEVIATION 10.6 | 40.4 years STANDARD_DEVIATION 9.1 | 40.6 years STANDARD_DEVIATION 12 | 39.1 years STANDARD_DEVIATION 11.2 | 38.7 years STANDARD_DEVIATION 8.9 | 39.5 years STANDARD_DEVIATION 8.3 | 39.4 years STANDARD_DEVIATION 12.9 | 40.8 years STANDARD_DEVIATION 12.2 | 40.5 years STANDARD_DEVIATION 9.9 | 31.4 years STANDARD_DEVIATION 9.1 | 40.2 years STANDARD_DEVIATION 11.2 | 41.7 years STANDARD_DEVIATION 10.9 | 43.2 years STANDARD_DEVIATION 14.2 | 40.0 years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 489 Participants | 17 Participants | 15 Participants | 15 Participants | 16 Participants | 14 Participants | 18 Participants | 16 Participants | 15 Participants | 16 Participants | 15 Participants | 14 Participants | 13 Participants | 14 Participants | 12 Participants | 16 Participants | 13 Participants | 17 Participants | 17 Participants | 17 Participants | 13 Participants | 17 Participants | 18 Participants | 16 Participants | 16 Participants | 13 Participants | 16 Participants | 18 Participants | 15 Participants | 11 Participants | 16 Participants | 18 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 4 Participants | 0 Participants | 0 Participants | 1 Participants | 4 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants | 0 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 20 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 16 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 87 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 5 Participants | 3 Participants | 1 Participants | 1 Participants | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 2 Participants | 1 Participants | 3 Participants | 3 Participants | 2 Participants | 5 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 5 Participants | 1 Participants | 2 Participants | 2 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other/Unknown | 36 Participants | 0 Participants | 1 Participants | 5 Participants | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White/Caucasian | 417 Participants | 16 Participants | 13 Participants | 10 Participants | 13 Participants | 9 Participants | 14 Participants | 13 Participants | 12 Participants | 14 Participants | 12 Participants | 14 Participants | 11 Participants | 14 Participants | 9 Participants | 15 Participants | 13 Participants | 14 Participants | 15 Participants | 15 Participants | 12 Participants | 12 Participants | 14 Participants | 14 Participants | 15 Participants | 10 Participants | 15 Participants | 15 Participants | 16 Participants | 12 Participants | 11 Participants | 15 Participants | 10 Participants |
| Sex: Female, Male Female | 459 Participants | 13 Participants | 13 Participants | 14 Participants | 14 Participants | 14 Participants | 14 Participants | 13 Participants | 14 Participants | 14 Participants | 14 Participants | 14 Participants | 13 Participants | 12 Participants | 14 Participants | 14 Participants | 14 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 16 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants |
| Sex: Female, Male Male | 103 Participants | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 3 Participants | 4 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants |
| Weight (kg) | 90.0 Kilograms STANDARD_DEVIATION 13.6 | 86.1 Kilograms STANDARD_DEVIATION 16 | 86.8 Kilograms STANDARD_DEVIATION 11.5 | 93.7 Kilograms STANDARD_DEVIATION 16.6 | 89.7 Kilograms STANDARD_DEVIATION 13.4 | 85.5 Kilograms STANDARD_DEVIATION 10.8 | 90.1 Kilograms STANDARD_DEVIATION 12 | 89.8 Kilograms STANDARD_DEVIATION 9.9 | 80.7 Kilograms STANDARD_DEVIATION 12.2 | 90.5 Kilograms STANDARD_DEVIATION 17.6 | 98.0 Kilograms STANDARD_DEVIATION 15.3 | 86.1 Kilograms STANDARD_DEVIATION 10.5 | 92.9 Kilograms STANDARD_DEVIATION 14.8 | 83.3 Kilograms STANDARD_DEVIATION 9.8 | 90.8 Kilograms STANDARD_DEVIATION 14.8 | 90.2 Kilograms STANDARD_DEVIATION 15.2 | 88.4 Kilograms STANDARD_DEVIATION 13.7 | 91.3 Kilograms STANDARD_DEVIATION 11.3 | 94.3 Kilograms STANDARD_DEVIATION 14.7 | 87.2 Kilograms STANDARD_DEVIATION 13.9 | 89.6 Kilograms STANDARD_DEVIATION 12.9 | 88.1 Kilograms STANDARD_DEVIATION 13.4 | 97.6 Kilograms STANDARD_DEVIATION 14.4 | 93.1 Kilograms STANDARD_DEVIATION 12.9 | 94.4 Kilograms STANDARD_DEVIATION 14.7 | 87.3 Kilograms STANDARD_DEVIATION 13.4 | 97.8 Kilograms STANDARD_DEVIATION 13.3 | 90.0 Kilograms STANDARD_DEVIATION 13.3 | 90.4 Kilograms STANDARD_DEVIATION 11.3 | 88.8 Kilograms STANDARD_DEVIATION 14 | 87.3 Kilograms STANDARD_DEVIATION 12 | 91.2 Kilograms STANDARD_DEVIATION 14 | 88.9 Kilograms STANDARD_DEVIATION 10.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 19 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 6 / 18 | 8 / 18 | 7 / 18 | 4 / 18 | 4 / 18 | 2 / 18 | 5 / 18 | 8 / 18 | 8 / 18 | 8 / 18 | 4 / 18 | 9 / 18 | 7 / 18 | 8 / 18 | 8 / 18 | 8 / 18 | 5 / 17 | 2 / 18 | 1 / 17 | 2 / 16 | 2 / 16 | 2 / 17 | 1 / 17 | 2 / 18 | 3 / 17 | 2 / 16 | 3 / 18 | 4 / 17 | 3 / 18 | 2 / 17 | 3 / 17 | 1 / 17 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 1 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 19 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 0 / 18 | 1 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 16 | 0 / 17 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 16 | 0 / 18 | 0 / 17 | 0 / 18 | 0 / 17 | 0 / 17 | 0 / 17 |
Outcome results
Primary
Weight Change (kg) From Baseline to Month 6, Main Effect of Time
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Time frame: From Baseline to Month 6
Population: ITT population: all randomized participants with at least one weight value. The decision to analyze all randomized participants together for aim 1, rather than separately by arm, was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the main effect of time.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Reporting Groups | Weight Change (kg) From Baseline to Month 6, Main Effect of Time | -4.8 Kg |
p-value: <0.001Mixed Models Analysis
Primary
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
Time frame: From Baseline to Month 6
Population: ITT population: all randomized participants with at least one weight value.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Reporting Groups | Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | .1244 Kg |
| PCP Reports | Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | -.0226 Kg |
| Text Messages | Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | .0840 Kg |
| Meal Replacements | Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | .1081 Kg |
| Buddy Training | Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction | -.4353 Kg |
p-value: 0.56795% CI: [-0.3026, 0.5513]Mixed Models Analysis
p-value: 0.91795% CI: [-0.4495, 0.4044]Mixed Models Analysis
p-value: 0.69995% CI: [-0.3429, 0.5109]Mixed Models Analysis
p-value: 0.61995% CI: [-0.3188, 0.535]Mixed Models Analysis
p-value: 0.04695% CI: [-0.8622, -0.0084]Mixed Models Analysis
Secondary
Intervention for <$500
Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.
Time frame: 6 months
Population: ITT population: weight loss data from all randomized participants with at least one weight value; combined with cost data for study implementation (staff time, supplies, etc.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Reporting Groups | Intervention for <$500 | 427 dollars |
Comparison: Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.p-value: 0.05195% CI: [-0.002, 0.85]Mixed Models Analysis
Other Pre-specified
Facilitation
Facilitation is an exploratory mediator that will be measured by rating how much the tools provided by the study have changed their environment and by the Weight Management Support Inventory
Time frame: 6 months
Other Pre-specified
Self-efficacy
Self-efficacy is an exploratory mediator that will be assessed to examine treatment effects on confidence about performing two categories of behaviors associated with weight loss: diet and physical activity
Time frame: 6 months
Other Pre-specified
Self-monitoring Adherence
Self-monitoring is a hypothesized mediator that will be operationalized as the number of days recording weight, dietary intake, and physical activity
Time frame: 6 months
Other Pre-specified
Self-Regulation
Self-regulation is an exploratory mediator that will be assessed using the Three Factor Eating Questionnaire and Treatment Self-Regulation Questionnaire
Time frame: 6 months
Other Pre-specified
Supportive Accountability
Supportive accountability is an exploratory mediator that will be measured by assessing two constructs that define supportive accountability: therapeutic alliance and perceived autonomy support
Time frame: 6 months
Other Pre-specified
Treatment Adherence
Treatment adherence is a hypothesized mediator that will be operationalized as the number of treatment sessions completed divided by the number of treatment sessions offered (12 or 24)
Time frame: 6 months