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

NCT05612971 | Active Not Recruiting DMC

• 2 other identifiers: STUDY00147611R01NR019810
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Weight Loss; Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mediator: Attendance

  Baseline, 3 months, 9 months

• Mediator: Reciprocal modeling

  Baseline, 3 months, 9 months

• Moderator: Family functioning

  Baseline, 3 months, 9 months

• Moderators: Genetic casual attributions

  Baseline, 3 months, 9 months

Other Outcomes (7)

• Participation rates and representativeness of school and clinic samples

  9 months

• The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews

  1 month and 10 months

• Physical activity

  Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months

Study Arms (3)

iAmHealthy Parents First

EXPERIMENTAL

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.

Behavioral: iAmHealthy Parents First

iAmHealthy

ACTIVE COMPARATOR

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.

Behavioral: iAmHealthy

iAmHealthy Parents First, Pilot, Non-Randomized

OTHER

Non-randomized feasiblity group. 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.

Behavioral: iAmHealthy Parents First

Interventions

iAmHealthy Parents First BEHAVIORAL

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.

iAmHealthy Parents First; iAmHealthy Parents First, Pilot, Non-Randomized

iAmHealthy BEHAVIORAL

The iAmHealthy group will receive newsletters for three months. Following this period, these dyads will take part in a 6-month family-based healthy lifestyles program.

iAmHealthy

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

• Davis AM, Befort CA, Lancaster BD, Tuck C, Polivka BJ, Carlson JA, Fleming K, Romine RS, Dean K, Murray M. Rationale and design of integrating a parents first obesity intervention with a pediatric weight management intervention for rural families - Evaluating the ripple effect. Contemp Clin Trials. 2023 May;128:107140. doi: 10.1016/j.cct.2023.107140. Epub 2023 Mar 7.

  PMID: 36893988 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Weight Loss; Pediatric Obesity

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Ann M Davis, PhD, MPH

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

• Christie Befort, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 14, 2022
• Study Start: October 23, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)