iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Families in Rural Kansas

Study Overview
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Brief Summary
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The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.

Detailed Description
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The goal of this project is to determine if an adult intervention followed by a family-based program (iAmHealthy Parents First) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iAmHealthy). Furthermore, the investigators aim to discover if administering iAmHealthy Parents First will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iAmHealthy. Parent/child dyads will be recruited from both rural elementary schools and rural medical clinics in 8 towns.

Official Title
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iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Families in Rural Kansas

Conditions
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Weight Loss, Pediatric Obesity

Intervention / Treatment
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* Behavioral: iAmHealthy Parents First
* Behavioral: Self-Guided


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Family lives in a rural area (city and/or county population < 20,000), RUCA (Rural-Urban Commuting Area Codes)=4-10 Child BMI%ile > 85th and parent BMI 27-50 kg/m2 Child in 1st-5th grade or 6-11 years of age Child and parent speak English Family is available at times intervention is offered Exclusion Criteria: For parents: new MI (myocardial infarction), stroke, or cancer diagnosis in past 6 months, history of bariatric surgery, pregnancy in last 6 months or planned within 1 year Child or parent has significant developmental or cognitive impairments or other significant medical issue known to school/clinic Parent or child has significant physical limitation Parent/child planning to move to a non-participating site

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iAmHealthy Parents First<br>iAmHealthy Parents First families will take part in a group program with other adults. These sessions will be delivered over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for 3 months. Each meeting will last approximately an hour and cover topics such as nutrition, physical activity, and meal planning. Fifteen dyads from each town 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 also take place over Zoom and will occur weekly for 4 months then bi-monthly for 2 months. | Behavioral: iAmHealthy Parents First<br>* iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program.<br>|
| Active Comparator: Self-Guided<br>Self-Guided 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 3 months. Fifteen dyads from each town will be randomized to the Self-Guided group. After 3 months, both iAmHealthy Parents First and Self-Guided families will take part in an educational group program with parents and their children. These meetings will also take place over Zoom and will occur weekly for 4 months then bi-monthly for 2 months. | Behavioral: Self-Guided<br>* The Self-Guided group will receive newsletters for 3 months. Following this period, these dyads will take part in a 6-month family-based healthy lifestyles program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent weight change in parents and BMIz (BMI z-score) in children | Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team. | Baseline, 3 months, 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mediator: Attendance | Group and individual session attendance (percent of sessions) will be tracked on REDCap, a secure, web-based application designed exclusively to support data capture for research studies. | Baseline, 3 months, 9 months | 
| Mediator: Reciprocal modeling | Reciprocal influence (parent response as mediator for child; child response as mediator for parent) will be operationalized as adult or child weight loss. | Baseline, 3 months, 9 months | 
| Moderator: Family functioning | Family functioning will be measured using the Family Assessment Device (FAD). This is the gold-standard measure of structural, organizational, and transactional characteristics of families including general family functioning (core scale of interest) and 6 additional subscales: affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles. This questionnaire will be completed by adults. The FAD is scored by adding responses of each scale (1 - 4) and dividing by the number of items in each scale (between 6 - 12). The higher the overall score, the worse the level of family function. | Baseline, 3 months, 9 months | 
| Moderators: Genetic casual attributions | Genetic casual attributions will be measured using a a 2-item Likert scale that assesses perceived genetic role for weight status and potential for weight loss. This will be completed by adults. Those who endorse completely or mostly for the role of genes in weight loss will be characterized as having high genetic attribution for weight status. | Baseline, 3 months, 9 months |