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The purpose of this pilot proposal are the following: 1) to determine the feasibility and acceptability of integrating the TOPS weight loss program into underserved populations through an urban safety net clinic and 2) to gather preliminary data of weight change to inform the design of a future randomized, controlled trial to determine the efficacy of the TOPS program in safety net clinics.
To achieve these goals, the investigators will pursue the following Specific Aims:
Specific Aim 1. Assess the feasibility and acceptability of integrating the TOPS program into an urban safety net clinic, with process measures (i.e., recruitment/refusal rates and retention/dropout rates) and focus groups.
Hypothesis 1. Integrating the TOPS program into an urban safety net clinic is feasible and acceptable to participants.
Specific Aim 2. Assess the percent of participants in the TOPS intervention arm with clinically significant weight change (i.e., weight loss of ≥5% of initial body weight) at 12, 26, and 52 weeks.
Hypothesis 2. 10%, 25%, and 33% of participants in the TOPS intervention arm will lose ≥5% of initial body weight at 12, 26, and 52 weeks, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TOPS | Experimental | Participants will attend weekly TOPS meetings with standard weekly weigh ins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TOPS | Other | Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Weight | Weekly weight data will be collected by the DOC Designee at baseline, 12, 24, and 52 weeks. | Baseline, 12, 24, and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Program Attendance | Calculate the percentage of TOPS at DOC group session attendance (sessions attended/total offered). | 52 Weeks |
| Retention as measured by attendance sheets | Calculate the retention of participants in the TOPS at DOC program at 12, 24, and 52 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nia S Mitchell, MD, MPH | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke General Internal Medicine | Durham | North Carolina | 27701 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C015535 | TOPS |
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| 12, 24 and 52 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |