Cooking Skills to Improve Long-Term Weight Loss in Young Adults With Intellectual Disabilities

Обзор

The goal of this study is to see if adding hands-on cooking classes to a weight management program (called Chef-ID) helps young adults with intellectual disabilities lose more weight and keep it off compared to a standard weight loss program. The study will last 24 months and include three phases: 6 months of active support, 12 months of maintenance, and 6 months with no contact. The investigators will look at how much weight participants lose over the first 18 months. Changes in cooking skills, body fat, health markers (like blood pressure and cholesterol), daily living skills, and caregiver stress will be tracked. Finally, factors that might help or prevent weight loss, and how changes in weight and body fat are linked to overall health will be explored. This research will help inform on how to better support healthy lifestyles for people with intellectual disabilities.

Подробное описание

This study will compare two different approaches to long-term weight loss in young adults (ages 18-30) with mild-to-moderate intellectual disabilities. One group will follow a traditional weight loss program (called eSLD), while the other will follow the same program plus take part in in-person cooking classes (called eSLD+Chef-ID). A total of 114 participants will be randomly assigned by computer to one of the two groups for a 24-month study, which includes 6 months of active support, 12 months of follow-up, and 6 months with no contact.

All participants will follow a simple diet called the "enhanced stoplight diet" and try to get at least 120 minutes of aerobic exercise and 30 minutes of strength training each week. Participants be given an iPad® with pre-recorded exercise videos, a wearable fitness tracker, and will have monthly Zoom check-ins with a health coach for 18 months.

Those in the eSLD+Chef-ID group will also attend fun, hands-on cooking classes twice a month during the first 6 months and once a month from months 7-18. Participants in the traditional eSLD group will receive short motivational video messages from their coach instead of cooking classes.

Weight will be measured at the beginning, 6, 12, 18, and 24 months. Other health measures like cooking skills, body fat, blood pressure, and caregiver stress will also be collected during lab and home visits. The goal is to find out whether learning to cook helps improve long-term weight loss and overall health in this community.

Вмешательства

• Поведенческое Weight Loss Plus Cooking
  Participants in the eSLD+Chef-ID group will follow a healthy eating plan using the enhanced stoplight diet, meet with a health coach once a month on Zoom® using an iPad®, and aim to get 120 minutes of aerobic activity and 30 minutes of strength exercises each week. In addition, they will attend in-person cooking classes-twice a month during the first 6 months and once a month for the next 12 months. In these 60-minute classes, instructors will teach cooking skills, and participants will practic
• Поведенческое Traditional Weight Loss
  Participants in the eSLD group will follow a healthy eating plan using the enhanced stoplight diet, meet once a month with a health coach on Zoom® using an iPad®, and aim to get 120 minutes of aerobic activity and 30 minutes of strength exercises each week. They will also receive short (2-minute) video messages from their coach-twice a month during the first 6 months and once a month after that. These videos will include feedback on their progress, reminders about their goals, and tips to help

Первичные конечные точки

• Weight Loss Between Arms [Срок оценки: Baseline to 18 months]

Вторичные конечные точки (12)

• Changes in Weight [Срок оценки: Baseline to 24 months]
• Activities of Daily Living [Срок оценки: Baseline to 24 months]
• Caregiver Strain [Срок оценки: Baseline to 24 months]
• Fat Mass [Срок оценки: Baseline to 18 months]
• Fat-free Mass [Срок оценки: Baseline to 18 months]
• Percent Body Fat [Срок оценки: Baseline to 18 months]
• High-density Lipoprotein (HDL) [Срок оценки: Baseline to 18 months]
• Low-density Lipoprotein (LDL) [Срок оценки: Baseline to 18 months]
• Fasting Glucose [Срок оценки: Baseline to 18 months]
• Hemoglobin A1c (HbA1c) [Срок оценки: Baseline to 18 months]
• Resting Blood Pressure [Срок оценки: Baseline to 18 months]
• Cooking Skills [Срок оценки: Baseline to 18 months]

Критерии участия

Критерии включения

• Diagnosis of mild-to-moderate intellectual disability (ID).
• 18-35 years of age.
• BMI >24.9, Body weight <350lbs.
• Sufficient functional ability to understand directions, communicate preferences, e.g., foods, wants, and can communicate through spoken language e.g., request more to eat/drink, asks for assistance with food preparation.
• Living at home with a parent/guardian, or in a supported living environment with a caregiver who assists with food shopping, meal planning, and meal preparation and agrees to serve as a study partner.
• Plan to attend all study required visits over the next 24 mos.

Критерии исключения

• Unable to participate in PA.
• Insulin dependent diabetes as this condition requires medical monitoring beyond the scope of this study.
• Participation in a weight management program involving diet, PA, or pharmacotherapy in the past 6 mos.
• Diagnosis of Prader-Willi Syndrome.
• Pregnancy during the previous 6 mos., currently lactating or planned pregnancy in the following 24 mos. Participants who become pregnant will be removed from the study and referred to appropriate agencies for consultation.
• Serious medical risk, e.g., cancer, recent heart attack, stroke, angioplasty as determined by the PCP.
• Unwilling to be randomized.
• Unable to participate in small group, in-person instruction.
• Use of wheelchair or power chair as primary locomotion.

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

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Kansas Medical Center — Kansas City

Идентификаторы

NCT: NCT06961591 · STUDY 160822 · R01HD116832

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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