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

Primary Purpose

Weight Loss, Pediatric Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iAmHealthy Parents First
Self-Guided
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iAmHealthy Parents First

Self-Guided

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 1, 2022
Last Updated
June 8, 2023
Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05612971
Brief Title
iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Families in Rural Kansas
Official Title
iAmHealthy Parents First: A Televideo Parent and Child Obesity Program for Families in Rural Kansas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 both rural elementary schools and rural medical clinics in 8 towns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Pediatric Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iAmHealthy Parents First
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-Guided
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
iAmHealthy Parents First
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Guided
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent weight change in parents and BMIz (BMI z-score) in children
Description
Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team.
Time Frame
Baseline, 3 months, 9 months
Secondary Outcome Measure Information:
Title
Mediator: Attendance
Description
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.
Time Frame
Baseline, 3 months, 9 months
Title
Mediator: Reciprocal modeling
Description
Reciprocal influence (parent response as mediator for child; child response as mediator for parent) will be operationalized as adult or child weight loss.
Time Frame
Baseline, 3 months, 9 months
Title
Moderator: Family functioning
Description
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.
Time Frame
Baseline, 3 months, 9 months
Title
Moderators: Genetic casual attributions
Description
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.
Time Frame
Baseline, 3 months, 9 months
Other Pre-specified Outcome Measures:
Title
Participation rates and representativeness of school and clinic samples
Description
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.
Time Frame
9 months
Title
The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews
Description
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.
Time Frame
1 month and 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Coordinator, MS
Phone
9135882042
Email
molalde@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann M Davis, PhD, MPH
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christie Befort, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Olalde
Email
molalde@kumc.edu

12. IPD Sharing Statement

Links:
URL
http://www.iamhealthyparentsfirst.org
Description
Study website

Learn more about this trial

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

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