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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met