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Family-Based Weight Loss Program for Childhood Obesity

N/A
Recruiting
Led By Justin Moore
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregiver who lives in the house with a BMI > 30
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will test whether a weight loss program that involves both kids and their parents is more effective than a program that just involves the kids.

Who is the study for?
This trial is for families where a child and their caregiver are both looking to lose weight. The caregiver must live with the child, have a BMI over 30, and be able to read and write in English. They should also be fit enough for physical activity and caloric restriction.
What is being tested?
The study tests Dyad Plus, a program aiming to improve family health by encouraging exercise, healthy eating habits, and weight loss through better self-monitoring, communication, problem-solving skills, and social support.
What are the potential side effects?
Since this trial involves lifestyle changes rather than medication there may not be typical 'side effects', but participants might experience muscle soreness from new physical activities or hunger if adjusting to a new diet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My caregiver at home is overweight.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BMI z-score
Secondary study objectives
Alanine Aminotransferase-Levels of ALT for all participants, measured in units per liter
Aspartate Transaminase
Caloric intake expressed in kcals
+8 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Co-enrollmentExperimental Treatment1 Intervention
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.
Group II: Caregivers of Adolescent ParticipantsExperimental Treatment1 Intervention
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.
Group III: Adolescent ParticipantsActive Control1 Intervention
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.

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Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,617 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,421 Total Patients Enrolled
Justin MoorePrincipal InvestigatorWake Forest University Health Sciences

Media Library

Brenner FIT Standard Clinical Trial Eligibility Overview. Trial Name: NCT04036331 — N/A
Childhood Obesity Research Study Groups: Co-enrollment, Caregivers of Adolescent Participants, Adolescent Participants
Childhood Obesity Clinical Trial 2023: Brenner FIT Standard Highlights & Side Effects. Trial Name: NCT04036331 — N/A
Brenner FIT Standard 2023 Treatment Timeline for Medical Study. Trial Name: NCT04036331 — N/A
~2 spots leftby Nov 2024
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