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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is a randomized controlled trial to evaluate the effect of an adapted version of the Body Project program among adult women of higher body weight who want to lose weight. The study will evaluate treatment effects on weight and shape concern and explore the impact of intervention on weight loss outcomes.
The objective of this study is to conduct a randomized controlled pilot trial to test the effects of a 28-week treatment protocol that combines a modified body image intervention (The Body Project: weeks 1-4) with a 6-month standard behavioral weight management treatment (weeks 5-28). The combined protocol will be evaluated in comparison to a control group that receives an education only program during weeks 1-4 followed by the same 6-month weight management treatment. It will be tested among women with high body weight who report High Weight and Shape Concern and would like to lose weight.
The goals of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Body Project | Experimental | Participants will receive this four week intervention followed by 6 months of behavioral weight management |
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| Facts about obesity, myths about weight loss | Active Comparator | Participants will receive this four week intervention followed by 6 months of behavioral weight management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Body Project | Behavioral | The Body Project, an evidence-based body image intervention developed for young women at risk for eating pathology, was adapted for use among adult women with high weight and shape concern and high body weight who want to lose weight. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight and shape concern | Assessed using the weight concern and shape concern subscales of the Eating Disorder Examination-Questionnaire. Subscale scores range from 0-6. | week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Momentary Weight and Shape Concern | Ecological momentary assessment will be used to assess in-the-moment thoughts about weight and shape on a 0-10 scale. | week 16, week 28 |
| Overeating | Ecological momentary assessment will be used to assess overeating in daily life. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Percent weight change will be calculated from weight at the start of weight loss treatment to program completion. | week 4 to week 28 |
| Adherence to lifestyle intervention | Adherence to exercise, dietary tracking, and self-weighing will be monitored throughout weight loss treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weight Control and Diabetes Research Center | Providence | Rhode Island | 02903 | United States |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Randomized controlled trial
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| Facts about obesity, myths about weight loss | Behavioral | This intervention is designed to help individuals prepare for weight loss and is focused on facts about obesity, myths about weight loss, and the importance of a varied diet. |
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| Lifestyle intervention for weight loss | Behavioral | This 24-week behavioral weight management program is based on the Look AHEAD and Diabetes Prevention Program manuals. It is designed to facilitate 7-10% weight loss of initial body weight through dietary and physical activity changes with use of behavioral strategies to support lifestyle changes over time. |
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| week 16, week 28 |
| week 4 to week 28 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |