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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK139059 | 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 find out what combination of components, if any, offers the best support for keeping weight off after someone loses weight. Long term weight loss maintenance is a challenge for many people who lose weight. There are many strategies, or components, people may use to avoid regain, but investigators do not know if there is a best, or optimal, combination of such components that can be done without adding a lot of cost or other burdens for people.
Participants will engage in a 16-week Phase 1 Weight Loss Program. Participants who lose 5% or more of their weight during that program will continue to Phase 2 Extended Care and be randomly assigned to 0, 1, 2, 3, or all of four methods of weight loss maintenance. They will use their assigned package for 12 months. Researchers will compare 16 different possible combinations of components and learn which of the 16 packages offers the best support for keeping weight off.
The four components participants could be assigned to in Phase 2 are:
Participants will have their weight measured and complete surveys 4 times if they complete both Phase 1 and Phase 2. During Phase 1, participants will attend weekly group sessions and be in touch with a study staff member investigators call a Wellness Coach. During Phase 2, participants will stay in touch with their Wellness Coach, use their assigned package, and answer questions about their experience periodically.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Package 1: No WLM Components | No Intervention | Participants will receive education and support for weight loss maintenance only. | |
| Package 2: One WLM Component - BTS | Active Comparator | Participants will receive education and support for weight loss maintenance and Buddy Training and Support. |
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| Package 3: One WLM Component - HBRT | Active Comparator | Participants will receive education and support for weight loss maintenance and Home-based Resistance Training |
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| Package 4: Two WLM Components - HBRT+BTS | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and Buddy Training and Support. |
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| Package 5: One WLM Component - ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Acceptance and Commitment (ACT) Workshops. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced Food Variety (RFV) | Behavioral | Participants engaged in reduced food variety (RFV) will be asked to choose a few high-calorie, low nutrient main meals and snacks to eat regularly. At the beginning of each month, they will choose one main meal (entrée) to eat at least 2 times a week and one snack food to eat at least 4 times a week within the month. They will have the option to keep or change their main meal and snack options from month to month. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight from time of randomization to 12 months | The primary outcome of the study is the change in weight measurement from the time of randomization (after Phase 1 initial weight loss/the beginning of Phase 2) until the follow up visit 12 months later. Participants' body weight will be measured to the nearest 0.1 kg at each point using a calibrated electronic scale. The change between these two measures will be calculated. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gareth Dutton | Contact | 205-934-6876 | gdutton@uabmc.edu | |
| Amy Dobelstein | Contact | 205-975-1059 | adobelst@uabmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35205 | United States |
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Investigators used the multiphase optimization strategy (MOST) as the ideal approach for the proposed study as, with the four proposed intervention components, identifying an optimal intervention through a single randomized controlled trial (RCT) with multiple arms or through multiple RCTs would be methodologically inefficient and resource-intensive. Given this, investigators rely on the eloquent and rigorous MOST-based optimization design, which leverages factorial experimentation to identify an optimal set of intervention component(s). In a factorial experiment, the goal is not to compare individual experimental conditions (in this case, 16 conditions), but to use combinations of conditions to estimate the main and interaction effects of the intervention components. Thus, numerous intervention components can be evaluated simultaneously while utilizing the entire randomized sample.
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| Package 6: Two WLM Components - BTS+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Buddy Training and Support and ACT Workshops. |
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| Package 7: Two WLM Components - HBRT+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training and ACT Workshops. |
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| Package 8: Three WLM Components - HBRT+BTS+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Home-based Resistance Training, Buddy Training and Support, and ACT Workshops. |
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| Package 9: One WLM Component - RFV | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety. |
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| Package 10: Two WLM Components - RFV+BTS | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Buddy Training and Support |
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| Package 11: Two WLM Components - RFV+HBRT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and Home-based Resistance Training. |
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| Package 12: Three WLM Components - RFV+HBRT+BTS | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and Buddy Training and Support. |
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| Package 13: Two WLM Components - RFV+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety and ACT Workshops. |
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| Package 14: Three WLM Components - RFV+BTS+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Buddy Training and Support, and ACT Workshops. |
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| Package 15: Three WLM Components - RFV+HBRT+ACT | Active Comparator | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, and ACT Workshops. |
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| Package 16: Four WLM Components: RFV+HBRT+BTS+ACT | Experimental | Participants will receive education and support for weight loss maintenance as well as Reduced Food Variety, Home-based Resistance Training, Buddy Training and Support, and ACT Workshops. |
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| Home-based Resistance Training (HBRT) | Behavioral | Participants assigned to receive home-based resistance training (also called strength training or lifting weights) will be asked to engage in at-home exercises that strengthen muscles at least 2 days each week (≤45 minutes per home session) and track their progress. They will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first two months of Phase 2 to learn these skills. They will receive exercise plans and equipment (sets of dumbbells, a rack to hold the dumbbells, and an exercise mat) needed to complete exercises. |
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| Buddy Training and Support (BTS) | Behavioral | Participants assigned to buddy training and support will be asked to identify an eligible friend or family member who is over 18 years old that can be their "buddy". Study staff will contact the buddy to be sure they are eligible, willing, and have all the details they need. The participant's buddy will be asked to attend up to 6 training sessions with the study staff, so they can learn the best ways to support the participant during the program. After the buddy completes training, they will be asked to check in with the participant 1-2 times each week about their progress. |
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| Acceptance and Commitment (ACT) Workshops | Behavioral | Participants assigned to receive Acceptance and Commitment (ACT) Workshops will be asked to attend 6, 1-hour group-based skills training workshops (in-person and/or remotely via Zoom) during the first three months of Phase 2. These workshops will help them develop skills to handle tough thoughts about weight control, keep their values in mind, and be mindful of their decisions and the impact of their decisions related to weight control. They will also be asked to apply ACT skills regularly during the rest of Phase 2. |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D015431 | Weight Loss |
| D015438 | Health Behavior |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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