跳至主要内容
临床试验/NCT04036331
NCT04036331已完成不适用

Effectiveness/Feasibility of A Coordinated Parent/Child Dyad Weight Loss Intervention:

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年7月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
BMI z-score

研究概览

简要总结

The purpose of this research is to determine the effectiveness of a coordinated program (Dyad Plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. Participants of the Brenner FIT (Families In Training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. Parents/guardians will receive the components of By Design Essentials.

详细描述

Brenner FIT is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity. By Design is an adult (>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. The preliminary data suggest that most adolescent youth who enroll in Brenner FIT have at least one adult caregiver who is eligible and would benefit from enrollment in By Design Essentials.

Participants will be randomized into 1 of 3 groups. This include Brenner FIT standard care, Brenner FIT standard care+ By Design Essentials, or Dyad Plus.

Brenner FIT Standard: After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.

By Design Essentials: A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).

Dyad Plus (combination of Brenner FIT and By Design Essentials):This will include all components of the standard Brenner FIT program and By Design Essentials. In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
13 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible for enrollment in Brenner FIT and/or By Design Essentials
  • Caregiver who lives in the house with a BMI > 30
  • No contraindication for physical activity or caloric restriction
  • Must be able to read and write English

排除标准

  • BMI < 30
  • Contraindication for physical activity or caloric restriction
  • Cannot read or write English

研究组 & 干预措施

Adolescent Participants

Active Comparator

Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.

干预措施: Brenner FIT Standard (Behavioral)

Caregivers of Adolescent Participants

Experimental

Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.

干预措施: By Design Essentials (Behavioral)

Co-enrollment

Experimental

This condition is for dyads that are co-enrolled in This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.

干预措施: Dyad Plus (Behavioral)

结局指标

主要结局

BMI z-score

时间窗: 6 months

Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

Feasibility and Acceptability of Implementation

时间窗: Month 6

We will examine screening, recruitment, retention, adherence, and overall perception of Brenner FIT and By Design components

BMI z-score

时间窗: Baseline

Weight status of caregivers and youth will be quantified through calculation of BMI derived from measurement of height and weight at the intake and follow-up visits. Both height (plus or minus 0.1 cm) and weight (plus or minus 0.5 kg) will be recorded twice and values will be averaged to produce the final value using a Tanita (registered trademark) digital scale and a Seca (registered trademark) Height Rod (respectively). BMI will be calculated as kg /m2. BMI z-score will be calculated using CDC growth charts.

次要结局

  • Physical Activity Assessment Tool (PAAT)-Adult(6 Months)
  • Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)(6 months)
  • Physical Activity Assessed Using Fitbit (Youth)(6 Months)
  • Concentration of fasting glucose for all participants, mg/dL(6 months)
  • Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)(6 months)
  • Concentration of fasting Insulin for all participants, mg/dL(6 months)
  • Hemoglobin A1c concentration for all participants, measured in percentage(6 months)
  • Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter(6 months)
  • Concentration of total cholesterol (mg/dL)(6 months)
  • Economic costs of the three intervention arms over duration of program (USD)(Month 6)
  • Diet for Parent and Youth(Baseline and 6 Months)
  • Physical Activity Assessment Tool (PAAT)-Adult(Baseline)
  • Physical Activity Assessed with Youth Physical Activity Questionnaire (YPAQ)(Baseline)
  • Physical Activity Assessed Using Fitbit (Youth)(Baseline)
  • Concentration of fasting glucose for all participants, mg/dL(Baseline)
  • Aspartate Aminotransferase -Levels of AST for all participants, measured in units per liter (IU/L)(Baseline)
  • Concentration of fasting Insulin for all participants, mg/dL(Baseline)
  • Hemoglobin A1c concentration for all participants, measured in percentage(Baseline)
  • Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter(Baseline)
  • Concentration of total cholesterol (mg/dL)(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验