Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic (TOPS at DOC)

Duke University

Status

Completed

Conditions

Obesity

Treatments

Other: TOPS

Study type

Interventional

Funder types

Other

Identifiers

NCT03202420

Pro00080518

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.