iAmHealthy Program for Family Obesity Management

Overseen By Megan Olalde, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas Medical Center

Disqualifiers: Recent MI, Stroke, Cancer, 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 explores the best way to help families manage obesity by comparing two approaches: starting with a parent-only group program (iAmHealthy Parents First) before transitioning to a family program, versus beginning directly with a family program. Participants in the parent-first group attend weekly online meetings for three months without their children, then join family sessions. Families living in rural areas with children in grades 1-5, where both the child and parent meet specific body mass index (BMI) criteria, might find this trial suitable. As an unphased trial, it offers families the opportunity to contribute to innovative strategies for managing obesity.

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 prior data suggests that this program is safe for family obesity management?

Research has shown that specific safety data from past studies for the iAmHealthy Parents First program is not available. This program assists adults in managing obesity by promoting behavior changes, beginning with a group program for parents. The trial is labeled "Not Applicable" in terms of phase, indicating it does not involve new drugs or invasive procedures but focuses on lifestyle changes. Generally, programs like this are safe and carry minimal risk. Participants typically experience few, if any, negative effects, as the emphasis is on learning and adopting healthy habits. However, consulting the trial coordinators for more detailed and personalized information is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iAmHealthy Program for Family Obesity Management because it offers a fresh approach to tackling obesity by focusing on family dynamics and behavioral change, rather than just individual dieting or exercise. Unlike many current treatments that emphasize individual weight loss through medication or solo dieting programs, this program involves parents first, creating a supportive environment for lifestyle changes. The iAmHealthy Parents First treatment is unique because it includes adult group sessions via Zoom that focus on education and support, without children initially, before transitioning to a family-based approach. This dual-phase structure aims to equip parents with the tools and knowledge to lead their families in adopting healthier habits, potentially leading to more sustainable, long-term weight management outcomes.

What evidence suggests that this trial's treatments could be effective for family obesity management?

Research has shown that beginning with parents in obesity programs can be effective. In this trial, the iAmHealthy Parents First approach focuses on parents before involving children in group sessions. Early results suggest this method can lead to better family lifestyle changes. Studies have found that when parents set a good example, it encourages healthier habits in children. Meanwhile, the iAmHealthy group will start their weight loss journey using self-guided methods. Both strategies aim to create a supportive environment for families to adopt long-term healthy behaviors. This trial tests these strategies as new ways to manage obesity in families. ^{1 2 3 5 6}

Who Is on the Research Team?

Ann M Davis, PhD, MPH

Principal Investigator

University of Kansas Medical Center

Christie Befort, PhD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• iAmHealthy Parents First
• Self-Guided

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.

How Is the Trial Designed?

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+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

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.

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]

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]

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]

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]

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]

Families with underweight or normal weight parents are more likely to have healthier family nutrition and physical activity environments, with 64.3% scoring high on the FNPA scale, compared to only 45.2% of families with overweight or obese parents.

Parents with lower BMI engage in more positive parenting behaviors, such as monitoring their child's diet and physical activity, which contributes to a less obesogenic home environment and promotes healthier habits in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Parental BMI and the Family Nutrition and Physical Activity Environment in a Community Sample. Williams, JE., Helsel, B., Griffin, SF., et al.[2018]

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 six-month study involving 38 children aged 7 to 13 showed that both individual and group strategies for managing childhood obesity led to positive changes in physical activity and eating habits.

The group educational program was particularly effective in increasing physical activity levels and reducing total cholesterol, while individual assistance improved fruit and vegetable intake, demonstrating that both approaches are viable for treating childhood obesity.

NCBI (Pubmed)

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?]. de Mello, ED., Luft, VC., Meyer, F.[2020]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712420/

Rationale and Design of Integrating a Parents First Obesity ... This paper describes the rationale and design of a randomized control trial evaluating the effectiveness of an integrated adult- and child- ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/49/NCT03304249/Prot_SAP_000.pdf

iAmHealthy: A Home-based Rural Pediatric Obesity ... The purpose of this study our primary aim is to assess the effectiveness of rural pediatric obesity treatment delivered virtually to family ...

3. kumc.edu kumc.edu/about/news/news-archive/rural-obesity-treatment-study.html

New study aims to curb obesity in rural Kansas The iAmHealthy Parents First study is the first randomized controlled trial in the world designed to examine the effectiveness of an integrated obesity ...

4. reporter.nih.gov reporter.nih.gov/project-details/11004150

iAmHealthy Parents First - NIH RePORTER The current study will assess the effectiveness of iAmHealthy Parents First (a 4-month parent-only intervention followed by a 6-month family- based program) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423000630

Rationale and design of integrating a parents first obesity ... This study is the first RCT to examine the effectiveness of an integrated adult- and child-focused obesity treatment program.

6. withpower.com withpower.com/trial/phase-obesity-2023-7a94d

iAmHealthy Program for Family Obesity Management Is the iAmHealthy Program for Family Obesity Management safe for humans? The research articles provided do not contain specific safety data for the iAmHealthy ...