Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: High Protein Diet Counceling, Standard Protein Diet Counceling, Protein Supplement, Supervised Exercise.
- Кому может быть актуально
- Состояния в реестре: Obesity & Overweight, Sarcopenia. Базовые параметры: 50 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Optimizing Adaptive Intensive Behavioral Therapy for Obesity During the Transition to Older Adulthood: A Sequential Multiple Assignment Randomized Trial
Обзор
To test adaptive intensive behavioral therapy strategies comprising dietary patterns with varying amounts of protein and including supplemental protein or resistance exercise training for promoting weight loss and attenuating lean mass loss in adults aged 50-75 with obesity.
Подробное описание
This Sequential Multiple Assignment Randomized Trial (SMART) seeks to identify the optimal initial dietary strategy (high vs. standard protein diets) and as-needed augmentation strategy (protein supplementation vs. supervised resistance exercise training) for behavioral weight loss in adults aged 50-75. Augmentation strategies will only be used for participants who do not achieve at least 3% weight loss and/or those who lose more than 1.5 kg of fat free mass (i.e., Non-Responders) after 8 weeks of group-based behavioral obesity treatment. Protein supplements and supervised resistance exercise training will be provided at no-cost to participants for weeks 9-16 of the study. Responders (i.e., achieving at least 3% weight loss and less than 1.5 kg loss of fat free mass) will continue with their initial high protein or standard protein diet assignment for the remainder of the trial. This SMART will enroll 250 adults aged 50-75 years with a BMI of at least 30 kg/m2. All participants will receive 1 year of behavioral obesity treatment including 16 weeks of weekly group-based treatment (active weight loss phase) followed by 36 weeks of monthly group sessions to promote continued engagement in dietary and exercise behaviors and long-term weight loss maintenance. The behavioral intervention will be delivered via Zoom. Data collection will occur at the University of Alabama at Birmingham and 5 study visits will be scheduled including: screening (to determine eligibility), prior to starting the weight loss intervention (baseline), and at weeks 8, 16, and 52.
Вмешательства
- Поведенческое High Protein Diet Counceling
16 week group-based weight loss program with counseling to consume a high protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. - Поведенческое Standard Protein Diet Counceling
16 week group-based weight loss program with counseling to consume a standard protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:27%. - Поведенческое Protein Supplement
Non-responders from either initial randomized group assigned to this intervention receive twice daily protein supplements. - Поведенческое Supervised Exercise
Non-responders from either initial randomized group assigned to this intervention receive twice weekly small-group supervised resistance exercise training sessions.
Первичные конечные точки
- Change in Body Weight [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fat Free Mass [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
Вторичные конечные точки (11)
- Change in Fat Mass [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting Glucose [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting Insulin [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting Hemoglobin A1C [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting LDL-cholesterol [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting HDL-cholesterol [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting Total Cholesterol [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Fasting Total Triglycerides [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Blood Pressure [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Hand Grip Strength [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
- Change in Lower Extremity Strength [Срок оценки: Baseline, 8 weeks, 16 weeks, 52 weeks]
Критерии участия
Критерии включения
- Male or female sex
- all racial and ethnic groups
- BMI: 30-50 kg/m2
- age 50-75 years
- postmenopausal status for ≥1 y if female sex
Критерии исключения
- <3 months stable use of other medications affecting body weight or appetite
- >450 pounds (due to weight limitations of the DXA)
- indication or previous diagnosis of sarcopenia
- existing kidney disease
- current binge eating disorder, anorexia, or bulimia
- untreated hyper- or hypothyroidism, cancer (except basal cell), gastrointestinal disorders affecting food intake or nutrient absorption; any other medical condition, as determined by the study physician, precluding a HP diet and/or daily exercise
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Последовательный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of Alabama at Birmingham — Birmingham
Идентификаторы
NCT: NCT07446907 · IRB-300016298