Small Changes Clinical Weight Loss Trial

Обзор

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

Вмешательства

• Поведенческое 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 groce
• Поведенческое Standard behavioral therapy for weight loss
  Participants will be provided guidance on cutting and counting calories, setting goals, reading labels, and portion sizes.

Первичные конечные точки

• Change in weight [Срок оценки: Baseline,12 weeks]

Вторичные конечные точки (9)

• Change in Hemoglobin A1C levels [Срок оценки: Baseline, 12 weeks]
• Change in triglycerides levels [Срок оценки: Baseline, 12 weeks]
• Change in total cholesterol levels [Срок оценки: Baseline, 12 weeks]
• Change in HDL cholesterol levels [Срок оценки: Baseline, 12 weeks]
• Change in fasting blood glucose levels [Срок оценки: Baseline, 12 weeks]
• Change in lean body mass [Срок оценки: baseline, week 4, week 8, week 12]
• Change in fat mass [Срок оценки: 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 [Срок оценки: From baseline to week 12]
• Attrition as assessed by number of participants that complete the study [Срок оценки: week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• The University of Texas Health Science Center at Houston — Houston
• Texas Tech University — Lubbock

Идентификаторы

NCT: NCT06668272 · HSC-SPH-24-0430

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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