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NCT Number: NCT06668272

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston, Houston, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in weight

    Time frame: Baseline,12 weeks

Secondary outcomes

  1. Change in Hemoglobin A1C levels

    Time frame: Baseline, 12 weeks

  2. Change in triglycerides levels

    Time frame: Baseline, 12 weeks

  3. Change in total cholesterol levels

    Time frame: Baseline, 12 weeks

  4. Change in HDL cholesterol levels

    Time frame: Baseline, 12 weeks

  5. Change in fasting blood glucose levels

    Time frame: Baseline, 12 weeks

  6. Change in lean body mass

    Time frame: baseline, week 4, week 8, week 12

  7. Change in fat mass

    Time frame: baseline, week 4, week 8, week 12

  8. Compliance as measured by the percentage of meals that follow the diet plan as reported in a daily food log

    Time frame: From baseline to week 12

  9. Attrition as assessed by number of participants that complete the study

    Time frame: week 12

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Aguilera

CONTACT

[email protected]

(915) 975-8520

Leah Whigham, PhD

CONTACT

[email protected]

(915) 975-8517

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 31, 2024
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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