iAmHealthy Program for Family Obesity Management

Recruiting in Palo Alto (17 mi)

Overseen by Ann M Davis, PhD, MPH

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kansas Medical Center

Disqualifiers: Recent MI, Stroke, Cancer, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing if starting with a program just for parents before doing a program for both parents and children together helps parents adopt healthy habits first so they can better support their children. The study targets parent/child pairs from rural areas in Kansas and neighboring states.

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of the iAmHealthy Program for Family Obesity Management treatment?

Research suggests that family-based interventions, especially those involving parents, can be effective in managing childhood obesity. Programs that focus on high attendance and self-regulation for both children and parents, as well as incorporating mobile health tools, have shown promise in reducing obesity. ^{1 2 3 4 5}

Is the iAmHealthy Program for Family Obesity Management safe for humans?

The research articles provided do not contain specific safety data for the iAmHealthy Program or its variations. They focus on feasibility, parental involvement, and the impact of parental BMI on family health behaviors, but do not address safety concerns directly. ^{2 6 7 8 9}

How is the iAmHealthy treatment for family obesity management different from other treatments?

The iAmHealthy treatment is unique because it focuses on a family-based approach, specifically targeting parents first to improve the success of obesity management in children. It leverages online technology to provide flexible, engaging, and tailored interventions that involve both parents and children, addressing barriers to accessing traditional in-person services. ^{2 6 10 11 12}

Research Team

Christie Befort, PhD

Principal Investigator

University of Kansas Medical Center

Ann M Davis, PhD, MPH

Principal Investigator

University of Kansas Medical Center

Eligibility Criteria

This trial is for families in rural Kansas with a child aged 6-11 who's overweight and parents also above a healthy weight. They must speak English and be available when the program is scheduled. Families can't join if the parent has had recent serious health issues, surgery for weight loss, or pregnancy; or if there are cognitive impairments or plans to move away.

Inclusion Criteria

My child is in 1st-5th grade or between 6-11 years old.

My child's BMI is above the 85th percentile and my BMI is between 27-50.

Family lives in a rural area (city and/or county population < 20,000), RUCA (Rural-Urban Commuting Area Codes)=4-10

Exclusion Criteria

My child or I have a major physical limitation.

Child or parent has significant developmental or cognitive impairments or other significant medical issue known to school/clinic

I am not planning to move to a place where the study is not conducted.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Parent Program

Adults participate in weekly group sessions over Zoom for three months without children

12 weeks

12 visits (virtual)

Family Program

Both iAmHealthy Parents First and iAmHealthy families participate in an educational group program with parents and children, focusing on healthy lifestyles

4 months

12 visits (virtual)

Extended Family Program

Three additional family-based group sessions spread over the final two months of the program

2 months

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• iAmHealthy Parents First (Behavioural Intervention)
• Self-Guided (Behavioural Intervention)

Trial Overview The study tests whether an obesity program that starts with just parents before including children is more effective than one involving both from the start. It uses televideo sessions aimed at improving family health habits.

Participant Groups

Group I: iAmHealthy Parents First Experimental Treatment 1 Intervention

iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. Fifteen dyads from each cohort will be randomized to the iAmHealthy Parents First group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. iAmHealthy Parents First adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program.

Group II: iAmHealthy Active Control 1 Intervention

iAmHealthy families will receive an informational newsletter once a month for three months. This group will be given the flexibility to start their weight loss journey using self-guided methods. No formal group sessions will be provided for three months. Fifteen dyads from each cohort will be randomized to the iAmHealthy group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program.

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+

Dr. Steve Stites

University of Kansas Medical Center

Chief Executive Officer

MD from University of Kansas School of Medicine

Dr. Matthias Salathe

University of Kansas Medical Center

Chief Medical Officer

MD from University of Kansas School of Medicine

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

The study involved 20 children and adolescents with obesity, who were randomized to either an mHealth intervention group using the Mandolean app or a control group receiving usual care, but faced a high attrition rate of 63% in the intervention group compared to 25% in the control group.

Low engagement with the Mandolean app and perceived task burden were significant barriers to adherence, suggesting that while self-monitoring tools like the myBigO app and smartwatches were acceptable, further improvements in the usability and acceptability of the Mandolean intervention are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. Browne, S., Kechadi, MT., O'Donnell, S., et al.[2021]

A 3-month family-based intervention for obese children from obese families resulted in significant weight loss and improved BMI percentiles compared to a control group, highlighting the efficacy of targeted interventions in this population.

The intervention also successfully reduced screen time and improved fitness levels, indicating that a combined approach addressing dietary, behavioral, and physical activity factors can lead to positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. Nemet, D., Barzilay-Teeni, N., Eliakim, A.[2020]

In a study of 75 participants in the Building Healthy Families program, those who achieved the largest reductions in BMI z-scores had high attendance and self-regulation skills, particularly among both children and mothers.

Successful outcomes were linked to mothers achieving clinically meaningful weight loss and children maintaining high attendance rates, suggesting that both parental involvement and self-regulation are crucial for effective obesity treatment in families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. Golden, CA., Heelan, KA., Hill, JL., et al.[2022]

A family-based intervention program targeting both parents and children resulted in significant long-term reductions in BMI-standard deviation score (BMI-SDS) after 2 years, indicating its effectiveness in addressing childhood obesity.

While both intervention groups (parents-only and parents-and-child) showed short-term improvements in BMI-SDS after 3 months, only the parents-and-child group maintained significant reductions at the 2-year follow-up, suggesting that involving children in the intervention may enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone. Yackobovitch-Gavan, M., Wolf Linhard, D., Nagelberg, N., et al.[2019]

A study involving 75 parents of children aged 4 to 18 years found that 90.3% were interested in an online family healthy lifestyle program, indicating strong demand for digital interventions in weight management.

Parents preferred a flexible, non-structured program that is easy to use and engaging, highlighting the importance of practical features and direct involvement of children in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Prevention and Management of Childhood Obesity: What Do Parents Want from an eHealth Program? Burrows, T., Hutchesson, M., Chai, LK., et al.[2022]

The Healthy Dads, Healthy Kids United Kingdom (HDHK-UK) program was well-received by participants, with 75% of those who attended at least one session participating in five or more sessions, indicating good adherence to the intervention.

Despite achieving a modest weight loss of 2.9 kg in the intervention group after 6 months, significant challenges in recruitment and follow-up led to the conclusion that the study was not feasible for a full randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT. Griffin, T., Sun, Y., Sidhu, M., et al.[2023]

Parents participating in a commercial weight loss program showed a significant decrease in their body mass index (BMI) after 8 weeks, indicating potential efficacy of such programs for adult weight management.

However, children in the study experienced an increase in their BMI and BMI percentile, suggesting that while parents improved their health behaviors, the impact on children's weight-related health behaviors may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility of parent participation in a commercial weight loss program to improve child body mass index and weight-related health behaviors. Song, M., Lee, CS., Lyons, KS., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. Ruebel, ML., Heelan, KA., Bartee, T., et al.[2019]

Parents often underestimate their children's engagement in weight control practices, indicating a gap in communication about health behaviors within families.

Children who are older, male, or have overweight are more likely to engage in unhealthy weight control practices and experience impaired family communication, suggesting these groups may need additional support in weight management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic reports of weight control practices, sedentary behaviors, and family functioning and communication between adult weight management patients and their children. Keeley J, P., Catherine A, V., Haley M, K., et al.[2022]

The Y W8? program, a 12-week family-based weight management course, effectively reduced the BMI of both children and parents, with significant decreases observed (children: pre-BMI 28.48 to post-BMI 27.48; parents: pre-BMI 30.77 to post-BMI 30.41).

The use of Bartholomew's Intervention Mapping framework was instrumental in developing this theory-based intervention, suggesting that structured planning can enhance the effectiveness of health programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using intervention mapping to develop a family-based childhood weight management programme. Pittson, H., Wallace, L.[2019]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps in Pediatric Obesity Treatment: Process Outcomes From a Feasibility Study of a Multicomponent Intervention. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Treatment of childhood obesity in obese families. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Qualitative Comparative Analysis of Program and Participant Factors That Explain Success in a Micropolitan Pediatric Weight Management Intervention. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

[Individual outpatient care versus group education programs. Which leads to greater change in dietary and physical activity habits for obese children?]. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Intervention for childhood obesity based on parents only or parents and child compared with follow-up alone. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition Interventions for Prevention and Management of Childhood Obesity: What Do Parents Want from an eHealth Program? [2022]

7. England pubmed.ncbi.nlm.nih.gov

Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Associations Between Parental BMI and the Family Nutrition and Physical Activity Environment in a Community Sample. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Assessing the feasibility of parent participation in a commercial weight loss program to improve child body mass index and weight-related health behaviors. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Outcomes of a Family Based Pediatric Obesity Program - Preliminary Results. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Dyadic reports of weight control practices, sedentary behaviors, and family functioning and communication between adult weight management patients and their children. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Using intervention mapping to develop a family-based childhood weight management programme. [2019]