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| ID | Type | Description | Link |
|---|---|---|---|
| R03DK095959 | 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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This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults.
This study is a 2-arm randomized controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of an MI-based program for weight loss in young adults. Participants will be assigned to either the MI Behavioral Weigh Loss or Behavioral Weight Loss arms - both arms will receive a 12-week Behavioral Weight Loss program, including 2 individual in-person sessions, followed by weekly Behavioral Weight Loss modules, reporting of key behaviors, and feedback on progress relative to goals, all via email. Session content will be quite distinct between the two arms, with an increased emphasis on personalized feedback relative to healthy norms, enhancing autonomous motivation, and choice surrounding diet and activity goals in the MIBWL arm. Assessments will take place at 0, and 3 months, followed by exit interviews to help refine the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivation Enhanced BWL | Active Comparator | 12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals. |
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| Brief Behavioral Weight Loss (BWL) | Active Comparator | 12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Behavioral Weight Loss (BWL) | Behavioral | 12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Primary Aims Include: Primary Aim 1: To determine the feasibility of an MI-based approach to weight loss in young adults. Specifically, to demonstrate that we can: 1) recruit 18-25 year olds into the proposed program, 2) keep them engaged, as evidenced by achieving >80% attendance and >80% completion of tracking / reporting activities, and 3) retain them for assessments, as evidence by achieving >80% retention at 12 and 24 week visits. | 12 weeks |
| Adherence | Primary Aim 2: To explore whether the MIBWL arm produces better adherence (see Aim 1, item 2), retention, autonomous motivation, and satisfaction, all of which may be related to better weight losses in the long-term. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | To explore whether the MIBWL arm is a viable approach to weight loss in this age group. Specifically, within group, we will examine mean weight change and proportion of participants achieving a clinically significant weight loss (>5%). Although not powered to detect differences, we will also explore differences in mean weight change between the MIBWL and BBWL groups. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica G LaRose, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 23298 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Motivation Enhanced BWL | Behavioral | 12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals. |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |