Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | December 22, 2017 |
| End Date: | January 10, 2020 |
Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
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.
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.
Inclusion Criteria:
- Participants must be patients of the DOC.
- BMI: Asian patients with a BMI of ≥23 kg/m2 and patients of other racial and ethnic
backgrounds will be included if have a BMI of ≥25 kg/m2. Asian patients are allowed to
participate at a BMI in the normal range because they are more likely to develop
diabetes (or insulin resistance or glucose intolerance at a BMI of 23 kg/m2).
Exclusion Criteria:
- Mental illness that would cause disruptions to group meetings
- Cognitive impairment that would preclude participants from understanding the program
- Type 2 diabetics on insulin or sulfonylureas without provider approval
- untreated hyper- or hypothyroidism
- current cancer diagnosis
- history of cancer (other than skin cancer)
- gastrointestinal disorders affecting food intake
- use of medications thought to effect metabolism, body weight, energy expenditure, or
appetite
- women currently pregnant or lactating, planning to become pregnant, or less than 6
months post-partum
- weight loss of > 5% in past 6 months
- major psychiatric disorder
- current moderate to severe symptoms of depression
- eating disorders
- current alcohol or substance abuse.
We found this trial at
1
site
6301 Herndon Road
Durham, North Carolina 27701
Durham, North Carolina 27701
Principal Investigator: Nia Mitchell, MD
Phone: 919-668-7214
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