Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
52 participants
INTERVENTIONAL
2024-11-01
2025-11-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Small Changes program
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
Standard behavioral therapy for weight loss
Standard behavioral therapy for weight loss
Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.
Interventions
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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
Standard behavioral therapy for weight loss
Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Leah Whigham
Associate Professor
Principal Investigators
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Leah Whigham, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Texas Tech University
Lubbock, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Leah Whigham, PhD
Role: primary
Juan Aguilera
Role: backup
Nikhil Dhurandhar, PhD
Role: primary
Gaurav Kudchadkar
Role: backup
Other Identifiers
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HSC-SPH-24-0430
Identifier Type: -
Identifier Source: org_study_id