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Family Matters Intervention for Childhood Obesity
N/A
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child with age and sex adjusted BMI ≥75th percentile (no upper limit).
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months post-baseline
Awards & highlights
Study Summary
This trial aims to improve child diet quality and decrease obesity by increasing family meal quality and quantity using innovative technology and partnerships with primary care and community health workers.
Who is the study for?
This trial is for children aged 5-10 with obesity (BMI ≥75th percentile) who have ≤3 family dinner meals per week. It includes their primary caregiver and at least one sibling, possibly other family members too. Participants must attend certain Minnesota clinics, not plan to move soon, speak English or Spanish, and come from diverse racial/ethnic backgrounds.Check my eligibility
What is being tested?
The study tests a 12-month program aimed at reducing childhood obesity by improving the quality and frequency of family meals using video feedback and real-time interventions through technology. It involves in-home visits, food preparation activities, and partnerships with healthcare workers.See study design
What are the potential side effects?
Since this intervention focuses on behavioral changes rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience changes in family dynamics or stress related to adapting new mealtime routines.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's BMI is in the top 25% for their age and sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12-months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Child BMI percentile
Child Dietary Quality
Secondary outcome measures
Family Meal Dietary Healthfulness
Family Meal Emotional Atmosphere Quality
Family Meal Quantity
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: EMI + HV + Video feedback, VirtualExperimental Treatment3 Interventions
EMI + HV + Video Feedback (Arm 2) education visits will all be delivered virtually, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.
Group II: EMI + HV + Video feedback, HybridExperimental Treatment4 Interventions
EMI + HV + Video Feedback (Arm 3) education visits will be delivered virtually and in-home, and the arm includes: (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; (2) bi-weekly in-home educational visits (total of 8) with a community health worker (CHW) focusing on family meal quality (i.e., dietary quality, interpersonal quality) and quantity (i.e., frequency of family meals), and 8 weeks "Try it Yourself" activities that reinforce the messages and skills taught by a CHW (for a total of 16 weeks); (3) video feedback on a video-taped family meal delivered every other week during the in-home visit with the CHW; (4) a 8-week maintenance phase with EMI tips delivered on high stress days.
Group III: EMIExperimental Treatment2 Interventions
EMI (Arm 1): (1) tailored ecological momentary intervention (EMI) prompts sent to parents targeting momentary behaviors (e.g., stress) around family meal quality and quantity for 16 weeks; and (2) a 8-week maintenance phase with EMI tips delivered on high stress days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ecological Momentary Intervention
2020
N/A
~230
Maintenance
2002
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,377 Previous Clinical Trials
1,587,771 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My child's BMI is in the top 25% for their age and sex.I am a non-custodial parent with less than 50% living time with my child.I am a child aged 5-10, visit specific clinics, and my caregiver and a sibling will join the study.I plan to stay in my current location for at least the next two years.My family and I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: EMI + HV + Video feedback, Hybrid
- Group 2: EMI
- Group 3: EMI + HV + Video feedback, Virtual
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.
Does the age threshold for this trial extend beyond sixty-five years old?
"To be considered for this trial, potential participants must range from 5 to 10 years old. There are 250 trials specifically geared towards minors and 603 studies targeting patients of a more advanced age."
Answered by AI
What goals has this clinical experiment set out to accomplish?
"The principal objectives of this study, which will be evaluated over a 12-month period post-baseline measurement is to assess Child Dietary Quality. Secondary outputs encompass Sibling BMI percentile (calculated using CDC guidelines and adjusted for sex and age), Family Meal Emotional Atmosphere Quality as determined by Iowa Family Interaction Rating Scales video recordings, and Parent Feeding Practices assessed three times throughout the duration of the trial via validated EMA surveys."
Answered by AI
Who is eligible to enroll in this clinical research program?
"To qualify for this research, participants must be between 5 and 10 years old and have a diagnosis of obesity. This medical trial is planning to recruit 525 individuals in total."
Answered by AI
Are there still opportunities for individuals to take part in this research endeavor?
"As per the information on clinicaltrials.gov, this experiment is not presently recruiting patients. The trial first appeared on February 11th 2022 and was last updated April 28th of that same year. Although this specific study is closed for enrollment at present, 1007 other medical trials are currently open to applicants."
Answered by AI
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