Clinical trial NCT05612971: iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Rural Families
Official title: iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Rural Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Loss
Pediatric Obesity
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Nursing Research (NINR)
First posted: 2022-11-14
Enrollment: 480
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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 rural elementary schools, medical clinics, and organizations across Kansas and neighboring states.

Eligibility criteria: Inclusion Criteria:

* Family lives in a rural area (city and/or county population \<20,000) or as defined by RUCA codes, Urban Influence Codes, amount of agricultural income, or individual commuting patterns
* Child BMI%ile ≥ 85th and parent BMI 25-50 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, stroke or cancer diagnosis in past 6 months, recent bariatrics surgery (within 2 years) or planned within 1 year, pregnancy in last 6 months or planned within 1 year

Primary outcomes:
measure: Percent weight change in parents and BMIz (BMI z-score) in children
timeFrame: Baseline, 3 months, 9 months
Secondary outcomes:
measure: Mediator: Attendance
timeFrame: Baseline, 3 months, 9 months
measure: Mediator: Reciprocal modeling
timeFrame: Baseline, 3 months, 9 months
measure: Moderator: Family functioning
timeFrame: Baseline, 3 months, 9 months
measure: Moderators: Genetic casual attributions
timeFrame: Baseline, 3 months, 9 months
Other outcomes:
measure: Participation rates and representativeness of school and clinic samples
timeFrame: 9 months
measure: The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews
timeFrame: 1 month and 10 months
measure: Physical activity
timeFrame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
measure: Child diet
timeFrame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
measure: Child pain
timeFrame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
measure: Home environment
timeFrame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
measure: Caregiver stress
timeFrame: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Ann M Davis, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kansas Medical Center
name: Christie Befort, PhD
role: PRINCIPAL_INVESTIGATOR
References: