Small Changes Clinical Weight Loss Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Small Changes program; Behavioral: Standard behavioral therapy for weight loss

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leah Whigham, PhD; Phone Number: (915) 975-8517; Email: Leah.D.Whigham@uth.tmc.edu
• Study Contact Backup: Name: Juan Aguilera; Phone Number: (915) 975-8520; Email: Juan.Aguilera@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
      • Contact: Juan Aguilera; Phone Number: (915) 975-8520; Email: Juan.Aguilera@uth.tmc.edu
      • Contact: Leah Whigham, PhD; Phone Number: 915-975-8517; Email: Leah.D.Whigham@uth.tmc.edu
    • Lubbock, Texas, United States, 79424
      • Texas Tech University
      • Contact: Nikhil Dhurandhar, PhD; Phone Number: 806-834-6446; Email: nikhil.dhurandhar@ttu.edu
      • Contact: Gaurav Kudchadkar; Phone Number: 806 834-6446; Email: gkudchad@ttu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Body Mass Index greater than or equal to 25
• Stable weight with less than a 5% body weight change in the past 3 months.
• Willingness and ability to follow a written dietary plan.
• Ambulatory and capable of attending bi-weekly in-person and phone appointments.
• Must reside in the geographic area for the duration of the 12-week study.
• Clearance for weight loss by their health care provider.

Exclusion Criteria:

• Pregnant or lactating.
• Acute medical conditions such as kidney disease, liver disease, pancreatitis, or cancer.
• A history of bariatric surgery or gastrointestinal resection.
• Current use of anti-obesity medications or diabetes medications, such as Glucagon-like peptide-1 receptor agonists (GLP-1RAs), that induce weight loss.
• A history of commercial weight loss program participation within the last six months.
• A history of anorexia nervosa or other eating disorders.
• A history of anxiety or depression.
• Extreme dietary restrictions or allergies that limit the ability to follow the weight loss plan.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small Changes program	Behavioral: Small Changes program; 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
Active Comparator: Standard behavioral therapy for weight loss	Behavioral: Standard behavioral therapy for weight loss; Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in weight	Baseline,12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin A1C levels	Baseline, 12 weeks
Change in triglycerides levels	Baseline, 12 weeks
Change in total cholesterol levels	Baseline, 12 weeks
Change in HDL cholesterol levels	Baseline, 12 weeks
Change in fasting blood glucose levels	Baseline, 12 weeks
Change in lean body mass	baseline, week 4, week 8, week 12
Change in fat mass	baseline, week 4, week 8, week 12
Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log	From baseline to week 12
Attrition as assessed by number of participants that complete the study	week 12

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Leah Whigham, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: weight loss; Small Changes
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: HSC-SPH-24-0430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No