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iAmHealthy Program for Family Obesity Management
N/A
Recruiting
Led By Ann M Davis, PhD, MPH
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month and 10 months
Awards & highlights
Study Summary
This trial is testing if giving parents a program before adding kids can help more than just a parent/child group program.
Who is the study for?
This trial is for families in rural Kansas with a child aged 6-11 who's overweight and parents also above a healthy weight. They must speak English and be available when the program is scheduled. Families can't join if the parent has had recent serious health issues, surgery for weight loss, or pregnancy; or if there are cognitive impairments or plans to move away.Check my eligibility
What is being tested?
The study tests whether an obesity program that starts with just parents before including children is more effective than one involving both from the start. It uses televideo sessions aimed at improving family health habits.See study design
What are the potential side effects?
Since this trial involves educational programs rather than medication, traditional side effects aren't expected. However, participants may experience changes in lifestyle that could affect daily routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 month and 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month and 10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent weight change in parents and BMIz (BMI z-score) in children
Secondary outcome measures
Mediator: Attendance
Mediator: Reciprocal modeling
Moderator: Family functioning
+1 moreOther outcome measures
Participation rates and representativeness of school and clinic samples
The impact of nurse engagement/leadership on participant reach and attendance as measured by the Community Engagement Survey and semi-structured interviews
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: iAmHealthy Parents FirstExperimental Treatment1 Intervention
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.
Group II: Self-GuidedActive Control1 Intervention
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.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,370 Total Patients Enrolled
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2,849 Patients Enrolled for Weight Loss
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
168,790 Total Patients Enrolled
10 Trials studying Weight Loss
102,277 Patients Enrolled for Weight Loss
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,376,081 Total Patients Enrolled
3 Trials studying Weight Loss
777 Patients Enrolled for Weight Loss
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child or I have a major physical limitation.My child is in 1st-5th grade or between 6-11 years old.I am not planning to move to a place where the study is not conducted.My child's BMI is above the 85th percentile and my BMI is between 27-50.Both my child and I can speak English.My family can be present when the treatment is scheduled.I am a parent without recent major health events or plans for pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: iAmHealthy Parents First
- Group 2: Self-Guided
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total sample size of participants for this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this study began on April 25th 2023 and is presently recruiting 480 patients from one site. The trial was last updated on June 8th, 2023."
Answered by AI
Does this experiment have open enrollment for participants?
"Affirmative. According to information on clinicaltrials.gov, the trial is currently enrolling participants which was initially posted on April 25th 2023 and most recently updated on June 8th 2023. The trial requires 480 individuals from one medical facility for the study."
Answered by AI
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