90 Participants Needed

Family-Based Weight Loss Program for Childhood Obesity

CR
JM
Overseen ByJustin Moore, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Family-Based Weight Loss Program for Childhood Obesity safe for participants?

Family-based weight loss programs, like Brenner FIT, have been used successfully in pediatric weight management and focus on healthy lifestyle changes, such as nutrition and physical activity, which are generally safe for children and their families.12345

How is the Brenner FIT treatment for childhood obesity different from other treatments?

Brenner FIT is unique because it focuses on a family-based approach, emphasizing the role of the home environment and parental behavior in supporting child weight loss, unlike other treatments that may not involve the family as extensively.14678

What data supports the effectiveness of the treatment Brenner FIT Standard, Brenner FIT, Families In Training, By Design Essentials, Dyad Plus, Dyad Plus, Brenner FIT, By Design Essentials for childhood obesity?

Research shows that family-based programs focusing on physical activity and healthy eating, like Brenner FIT, can help children and their parents lose weight. In one study, children lost an average of 2.3 kg over 12 weeks, and their parents lost 6.4 kg, indicating that involving the whole family can lead to healthier lifestyles.1491011

Who Is on the Research Team?

JM

Justin Moore

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be able to read and write English
Eligible for enrollment in Brenner FIT and/or By Design Essentials
My caregiver at home is overweight.
See 1 more

Exclusion Criteria

BMI < 30
Cannot read or write English
You are unable to exercise or follow a restricted diet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive Brenner FIT standard care, By Design Essentials, or Dyad Plus interventions, including monthly visits and group sessions over 6 months

6 months
Monthly visits (in-person), group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Brenner FIT Standard
  • By Design Essentials
  • Dyad Plus
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Published Research Related to This Trial

In a 12-week family-based program called Building Healthy Families, 22 obese children lost an average of 2.3 kg, while their parents lost an average of 6.4 kg, indicating the program's effectiveness in promoting weight loss for both children and parents.
The study found that reducing the intake of high-fat, high-calorie foods was a strong predictor of weight loss in children, highlighting the importance of dietary changes in successful obesity treatment.
Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results.Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]
In a multicenter randomized controlled trial involving families with at least one overweight parent and a healthy child, changes in the mother's body mass index (BMI) were positively associated with changes in the BMI-for-age Z-scores of both children, indicating that parental weight management can influence children's weight outcomes.
The study highlights the effectiveness of family-based dietary interventions for weight maintenance, suggesting that including parents in these programs can benefit children's weight management, regardless of the child's initial weight status.
The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes).Pang, MD., Yilmaz, H., Astrup, A., et al.[2022]
A 2-year camp-based family treatment program for obesity showed a lower increase in BMI for children compared to an outpatient program, but did not result in significant differences in BMI SD scores between the two groups.
Both treatment approaches led to small reductions in parental BMI, but these changes were not significantly different, indicating that neither program was more effective than the other in the long term.
Camp-based family treatment of childhood obesity: randomised controlled trial.Benestad, B., Lekhal, S., Smรฅstuen, MC., et al.[2022]

Citations

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]
The association of changes in body mass index and metabolic parameters between adults with overweight or obesity and their children in a family-based randomized trial (DiOGenes). [2022]
Camp-based family treatment of childhood obesity: randomised controlled trial. [2022]
Family-based behavioural treatment of childhood obesity in a UK National Health Service setting: randomized controlled trial. [2022]
A Clinical Trial to Increase Self-Monitoring of Physical Activity and Eating Behaviors Among Adolescents: Protocol for the ImPACT Feasibility Study. [2020]
The CANadian Pediatric Weight management Registry (CANPWR): study protocol. [2021]
Assessing the feasibility of parent participation in a commercial weight loss program to improve child body mass index and weight-related health behaviors. [2022]
Prevention and Treatment of Pediatric Obesity: A Strategy Involving Children, Adolescents and the Family for Improved Body Composition. [2019]
ENTREN-F family-system based intervention for managing childhood obesity: Study protocol for a randomized controlled trial at primary care. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Fit Kids/Fit Families: a report on a countywide effort to promote healthy behaviors. [2008]
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