Small Changes Clinical Weight Loss Trial

NCT06668272 | Not Yet Recruiting

• 1 other identifier: HSC-SPH-24-0430
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity

Keywords

Small Changes; weight loss

Outcome Measures

Primary Outcomes (1)

• Change in weight

  Baseline,12 weeks

Secondary Outcomes (9)

• 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

Study Arms (2)

Small Changes program

EXPERIMENTAL

Behavioral: Small Changes program

Standard behavioral therapy for weight loss

ACTIVE COMPARATOR

Behavioral: Standard behavioral therapy for weight loss

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

Small Changes program

Standard behavioral therapy for weight loss BEHAVIORAL

Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.

Standard behavioral therapy for weight loss

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (2)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Texas Tech University

Lubbock, Texas, 79424, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Leah Whigham, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leah Whigham, PhD

CONTACT

(915) 975-8517; Leah.D.Whigham@uth.tmc.edu

Juan Aguilera

CONTACT

(915) 975-8520; Juan.Aguilera@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)