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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612971
• Other study ID #: STUDY00147611
• Secondary ID: R01NR019810
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2023
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: University of Kansas Medical Center
• Contact: Megan Coordinator, MS
• Phone: 9135882042
• Email: molalde[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Weight Loss

Intervention

Behavioral:
• iAmHealthy Parents First
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
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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Kansas Medical Center	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participation rates and representativeness of school and clinic samples	Reach (participation rates and representativeness) will be assessed at primary care versus school settings. Participation rates will be calculated in multiple ways to include: 1) the percentage of individuals on lists who respond and 2) the percentage of eligible respondents who enroll. Enrolled participants will be classified as recruited from the school or clinic according to participant self-report of how they heard about the study, or if recruited from both channels, which one had the most influence on their participation. Representativeness will be assessed by comparing demographics (age/grade, sex, race/ethnicity, BMI where available) between enrolled participants and non-participants including 1) potential participants on recruitment lists and 2) those who are screened but do not enroll. In addition, the investigators will assess the impact of nurse engagement/leadership on participant reach and attendance.	9 months
Other	The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews	The Community Engagement Survey will assess nurse engagement and leadership, which is divided into seven separately summed subscales. Interview data collection and analysis will be led by Co-I who has the necessary training/experience to conduct semi-structured interviews, with assistance from members of the research team. Dedoose will be used to assist the researchers in efficient and organized data storage, coding, retrieval, comparing, and linking.	1 month and 10 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study website