Small Changes Clinical Weight Loss Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06668272
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Small Changes program — BEHAVIORAL
    Participants will be asked to track their compliance with their Small Changes diet plan using a simple checklist record . Participants will be asked to follow their diet plan every day. They are encouraged to create a diet plan that is as close to their current diet as possible. Meal options include make-from-scratch recipes, quick "grab-and-go" options,and restaurant options. There may be some time involved in learning the recipes and the routine of their new diet. It also may alter their grocery spending and habits somewhat
  • Standard behavioral therapy for weight loss — BEHAVIORAL
    Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.

Study Details

The purpose of this study is to assess the effectiveness of the Small Changes program in facilitating weight loss and to assess treatment effects on body composition, blood markers of metabolic health, and blood pressure, and to assess attrition and compliance

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2024
Primary completion
Nov 1, 2025
Completion
Nov 1, 2025

Study Design

Enrollment
52 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Small Changes program
  • Active Comparator: Standard behavioral therapy for weight loss

Primary Outcome Measure

Change in weight [ Time Frame: Baseline,12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Leah Whigham, PhD
915-975-8517
Juan Aguilera
(915) 975-8520
Texas Tech UniversityLubbockTexas79424
Nikhil Dhurandhar, PhD
806-834-6446
Gaurav Kudchadkar
806 834-6446

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