GOAL Program for Childhood Obesity

(GOAL Trial)

Not currently recruiting at 1 trial location

Overseen By Lorraine B Robbins, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Michigan State University

Must not be taking: Appetite, weight, growth medications

Disqualifiers: Mental, physical health conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 27

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young adolescents improve their health by encouraging more physical activity and healthier eating habits. It includes a fun after-school club, parent-adolescent meetings, and a special website for parents. The goal is to reduce risks like high body fat and low fitness while boosting motivation and support. Kids in grades 5-8 who can join after-school activities and have a supportive parent or guardian might be a good fit. Participants will be randomly assigned to either the new program, Guys/Girls Opt for Activities for Life (GOAL), or continue with their usual school activities.

As an unphased trial, this study provides a unique opportunity for families to engage in a supportive community focused on enhancing adolescent health and well-being.

Will I have to stop taking my current medications?

If you are taking medications that alter appetite, weight, or growth, you will not be able to participate in the trial. Therefore, you would need to stop taking such medications to join.

What prior data suggests that the GOAL program is safe for adolescents?

Research has shown that the Guys/Girls Opt for Activities for Life (GOAL) program has previously achieved good results. The program encourages teenagers to be more active and eat healthier, which are generally safe activities. No reports of serious problems have emerged from this type of program.

The program includes activities like exercise, cooking, and social support, making it very safe. Being active and eating well are important for good health and are usually manageable for most teenagers. Similar programs have managed childhood obesity without major safety issues.

In summary, the GOAL program is based on safe activities that promote health and has a strong safety record from past use. Participants can expect to engage in activities designed to improve their health in a supportive setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GOAL Program for Childhood Obesity because it takes a holistic approach by involving both kids and their parents in the lifestyle change process. Unlike standard options that might focus solely on diet or exercise, this program combines after-school clubs, parent-adolescent meetings, and a social networking website to create a supportive environment. The program's emphasis on family engagement and community support aims to make healthy habits stick, potentially leading to lasting results in combating childhood obesity.

What evidence suggests that the GOAL program is effective for childhood obesity?

Research shows that programs like GOAL, conducted at schools and homes, can help reduce childhood obesity. In this trial, some participants will receive the GOAL intervention, which encourages teens to be more active and eat healthier. Similar programs have successfully helped kids lose weight and improve their overall health. Early results suggest that these methods can lead to better lifestyle habits, enhancing both physical health and quality of life. Programs involving family and providing social support are particularly effective in helping kids maintain these healthy changes. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

The GOAL trial is for boys and girls in 5th-8th grade (ages 10-14) who can understand English, with parents willing to participate. It's open to all interested students, not just those with high BMI, to avoid stigma. Parents need internet access and a device capable of receiving text messages.

Inclusion Criteria

I am willing and able to join the GOAL study.

available for follow up (9 months after intervention ends)

I am a student in 5th to 8th grade.

Exclusion Criteria

Parent/guardian exclusion criteria are:

I am taking medication that affects my appetite, weight, or growth.

I am not interested in learning to post.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person or virtual)

Intervention

The 16-week GOAL intervention includes after-school clubs, parent-adolescent meetings, and a social networking website to promote physical activity and healthy eating.

16 weeks

26 events (in-person), 3 meetings (1 in-person/virtual, 2 virtual)

Post-Intervention

Data collection occurs immediately after the intervention to assess changes in physical activity, diet, and other health metrics.

1-2 weeks

Data collection at school

Follow-up

Participants are monitored for long-term effects on physical activity, diet, and health metrics 9 months after the intervention.

9 months

Data collection at school

What Are the Treatments Tested in This Trial?

Interventions

• Guys/Girls Opt for Activities for Life (GOAL)

Trial Overview GOAL aims to increase physical activity and healthy eating among young adolescents through after-school clubs, parent meetings, and a social networking site for parents. The trial will compare the effects of this intervention against usual school activities on cardiovascular health and quality of life.

How Is the Trial Designed?

Group I: Guys/Girls Opt for Activities for Life Intervention (GOAL) Experimental Treatment 1 Intervention

Receives the 4 month (16-wk) GOAL intervention, which has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 wks due to no club during 3 school break wks) for boys and girls to engage in physical activity and healthy eating and cooking activities; (2) Three parent-adolescent meetings (1st meeting at each school with parents and adolescents \[Zoom option if needed\]; 2nd and 3rd meetings delivered virtually for parents): to empower parents to assist adolescents with physical activity and healthy eating and cooking; and (3) GOAL social networking website: private website for parents to share with each other how they helped their adolescent increase physical activity and diet quality each week.

Group II: Control Active Control 1 Intervention

Received usual school activities.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Participation in the Fit2Play™ afterschool program led to significant reductions in body mass index (BMI) percentiles for overweight and obese children, indicating effective weight management over one school year with 1546 participants.

The program also improved cardiovascular health, as evidenced by significant decreases in systolic and diastolic blood pressure, along with enhanced fitness levels and nutrition knowledge among all participants, highlighting its potential as a valuable intervention for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a park-based afterschool program replicated over five years on modifiable cardiovascular disease risk factors. Messiah, SE., Vidot, D., Hansen, E., et al.[2022]

In a study of 394 obese youth aged 5 to 19, participation in a family-centered outpatient weight management program led to significant reductions in weight, BMI, and BMI z score over an average of 5.6 months, without hindering growth.

Improvements in metabolic health were also observed, with many participants achieving normal blood pressure, cholesterol, and insulin levels by the end of treatment, indicating that even modest weight loss can lead to substantial health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of health outcomes to improvement in BMI in children and adolescents. Kirk, S., Zeller, M., Claytor, R., et al.[2013]

School-based interventions can lead to long-term positive health behavior changes in children, as they spend a significant amount of time in school, although their impact on weight measures is less clear due to common limitations.

Family-based interventions are effective in influencing children's behaviors, but issues like selection bias and high dropout rates can affect the reliability of their results; thus, a multidisciplinary approach that includes both school and family involvement is recommended for managing childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlling childhood obesity: A systematic review on strategies and challenges. Kelishadi, R., Azizi-Soleiman, F.[2022]

Participation in an 8-day summer camp for children with obesity led to a significant increase in moderate- to vigorous-intensity physical activity (MVPA) for male participants, while female participants did not show a similar increase, highlighting a gender difference in response to the camp activities.

The study suggests that summer camps can effectively improve physical activity levels in obese children, but special attention should be given to female participants to enhance their engagement and reduce sedentary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objectively Measured Physical Activity Increases Only in Males During a Summer Camp for Obese Children. Izzicupo, P., Di Blasio, A., Di Credico, A., et al.[2021]

In a study of 3090 overweight and obese children participating in the Go4Fun program, attending at least five sessions led to significant improvements in BMI z-score, fruit and vegetable intake, and physical activity levels.

Children whose mothers had lower educational qualifications showed less improvement in BMI and vegetable intake, but those attending seven or more sessions had better outcomes, highlighting the importance of both session attendance and maternal education in obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose response relationship between program attendance and children's outcomes in a community based weight management program for children and their families. Khanal, S., Choi, L., Innes-Hughes, C., et al.[2020]

The GOALS intervention led to a significant reduction in child BMI z-score by 0.07, which was maintained 12 months after the program, indicating its effectiveness in addressing childhood obesity.

Parents reported positive changes in family physical activity and dietary behaviors, suggesting that the program successfully promoted a whole-family approach to lifestyle changes, although there were no significant changes in parent BMI or child self-perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Service evaluation of the GOALS family-based childhood obesity treatment intervention during the first 3 years of implementation. Watson, PM., Dugdill, L., Pickering, K., et al.[2022]

The review identified a total of four new randomized controlled trials and two systematic reviews, indicating a significant increase in research on childhood obesity prevention and treatment since previous reviews, but high-quality evidence remains limited.

While there is some promise in targeting reductions in sedentary behavior and increasing physical activity for treating pediatric obesity, the effectiveness of these interventions is still uncertain, and more research is needed, especially outside the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity interventions in the prevention and treatment of paediatric obesity: systematic review and critical appraisal. Reilly, JJ., McDowell, ZC.[2022]

Citations

1. withpower.com withpower.com/trial/phase-3-pediatric-obesity-8-2020-69a7a

GOAL Program for Childhood Obesity · Info for Participants The GOALS family-based program showed positive impacts on childhood obesity over three years, and similar multidisciplinary programs have improved body weight, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10773393/

Intervention to increase physical activity and healthy eating ... A 16-week intervention called Guys/Girls Opt for Activities for Life (GOAL) was designed. The purpose of this randomised controlled trial is to evaluate any ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04213014

Guys/Girls Opt for Activities for Life Trial (GOAL) to Increase ... Adolescents will complete 2 non-consecutive 24-hr dietary recalls (1 weekend day; 1 weekday; randomly selected) over 2-3 weeks at baseline and post- ...

4. nursing.msu.edu nursing.msu.edu/research/research-projects/goal-guysgirls-opt-activities-life

GOAL: Guys/Girls Opt for Activities for Life A new school- and home-based program will help fight the growing childhood obesity epidemic. The program includes: An after-school club.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38171630/

Intervention to increase physical activity and healthy eating ... The purpose of this randomised controlled trial is to evaluate any effect of the intervention, compared with a control condition, on improving:

6. clinicaltrial.be clinicaltrial.be/fr/details/4259?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

Guys/Girls Opt for Activities for Life Trial (GOAL) to In... On average, we will include at least 63 adolescents (at least 31-32 boys and 31-32 girls) in each of 14 schools.