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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01DK134800-01A1 | 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 develop and test an adaptive, individually tailored intervention to prevent weight regain in people who have intentionally lost weight. The main questions it aims to answer are:
Participants will:
Participants will also engage in a 26-week program, which involves:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adaptive Intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive weight regain prevention | Behavioral | Adaptive intervention that will tailor participant re-engagement with professional support (e.g. health coaches) based on behavioral triggers and anthropometric monitoring (diet changes, weight increase, failure to weigh weekly). |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Participant Retention | Number of participants who continue to participate for all 26 weeks of the study and complete all study activities | From enrollment to the end of the 26-week monitoring period |
| Feasibility - Participant Adherence | Number of participants who complete all study activities, including weekly weigh-ins, weekly surveys, and pre/post study visits. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Participant Weight | From enrollment to the end of the 26-week monitoring period | |
| Efficacy - Participant Dietary Intake | Dietary and nutritional data collected via self-report using the ASA24 (Automated Self-Administered 24-Hour Dietary Assessment Tool). This includes calories, protein, fats, and other nutrition information based on participant self-report of meals. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Eating Self-Efficacy in High-Risk Situations | Eating self-efficacy in high-risk situations will be measured pre- & post-intervention using the Weight Efficacy Lifestyle Questionnaire. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Eating Behavior Patterns | Eating behavior patterns will be measured pre- & post-intervention using the Three-Factor Eating Questionnaire. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Sleep/Rest Duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josh Oliver | Contact | 971-645-6693 | joshua.oliver@hsc.utah.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Sleep/rest duration will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days. |
| From enrollment to the end of the 26-week monitoring period |
| Efficacy - Daily Step Count | Daily step count will be measured using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Sedentary Behavior (Sitting/Lying Time) | Sedentary behavior will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days. | From enrollment to the end of the 26-week monitoring period |
| Efficacy - Standing Time | Standing time will be measured in hours/day using the activPAL accelerometer, a thigh-worn device that objectively measures posture and movement. Participants will wear the device continuously for 7 consecutive days. | From enrollment to the end of the 26-week monitoring period |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |