Clinical trial NCT03202420: Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
Official title: Pilot Study to Test the Feasibility, Acceptability, and Weight Change of Take Off Pounds Sensibly (TOPS) in a Safety Net Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 12, 24, and 52 weeks
Secondary outcomes:
measure: Program Attendance
timeFrame: 52 Weeks
measure: Retention as measured by attendance sheets
timeFrame: 12, 24 and 52 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke General Internal Medicine
state: North Carolina
Study officials:
affiliation: Duke University
name: Nia S Mitchell, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: