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Family Support Interventions for Weight Loss in African American Families

N/A
Recruiting
Led By Lorna McNeill
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
PARENT/CAREGIVER: Are obese (BMI greater than or equal to 30)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights

Study Summary

This trial tests how well parent and family support interventions help African American families lose weight.

Who is the study for?
This trial is for African American families where a parent or caregiver and a child aged 10-16, living together, want to participate in weight loss interventions. The adult must be obese (BMI ≥30), not in other weight programs, and able to speak English. Pregnant individuals or those planning pregnancy during the study are excluded.Check my eligibility
What is being tested?
The study examines if educational activities, informational sessions, questionnaires, and support group therapy can help with family-oriented weight loss among African Americans. It focuses on parents as key agents of change within the family setting.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like education and support groups rather than drugs or medical procedures, it may not have typical side effects; however participants might experience emotional discomfort or stress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a parent or caregiver aged between 18 and 65.
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I am a parent/caregiver and my BMI is 30 or higher.
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I am a parent or custodial grandparent ready to participate with my child.
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I am enrolling with my child who is between 10 and 16 years old.
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I am between 10 and 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adoption (Part 3 of the RE-AIM framework)
Effectiveness (Part 2 of the RE-AIM framework)
Implementation (Part 4 of the RE-AIM framework)
+3 more
Secondary outcome measures
Blood pressure
Body fat percentage
Child's body mass index (BMI) z-score
+3 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group II (coaching session, navigation session, support group)Experimental Treatment4 Interventions
Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
Group II: Group I (coaching session, navigation session, support group)Experimental Treatment4 Interventions
Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
Group III: Group III (educational handbook)Active Control2 Interventions
Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Support Group Therapy
2021
N/A
~80

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,803,602 Total Patients Enrolled
Lorna McNeillPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
445 Total Patients Enrolled

Media Library

Parent and Family Oriented Support Interventions Clinical Trial Eligibility Overview. Trial Name: NCT04644224 — N/A
Cancer Research Study Groups: Group III (educational handbook), Group I (coaching session, navigation session, support group), Group II (coaching session, navigation session, support group)
Cancer Clinical Trial 2023: Parent and Family Oriented Support Interventions Highlights & Side Effects. Trial Name: NCT04644224 — N/A
Parent and Family Oriented Support Interventions 2023 Treatment Timeline for Medical Study. Trial Name: NCT04644224 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patient criteria for this clinical trial?

"This study needs 1632 obese participants, aged 10-65, who also fit the following criteria: DYAD: Parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate, PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old, PARENT/CAREGIVER: Are not currently participating in a physical activity (PA), diet, or weight management program, PARENT/CAREGIVER: Have a valid home address, telephone number, and internet access, PARENT/CAREGIVER: Enroll with a child aged 10-"

Answered by AI

What is the projected cohort size for this research project?

"Yes, the information on clinicaltrials.gov confirms that this trial is actively recruiting patients. The trial was first posted on January 1, 2019 and was last updated on September 22, 2022. The study is looking for 1632 patients across 1 site."

Answered by AI

Will this experiment be testing elderly patients?

"This particular clinical trial is designed for people aged 10-65. In contrast, there are 513 clinical trials for people aged under 18 and 2858 clinical trials for patients aged over 65."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families
2019. "Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04644224.
~565 spots leftby Dec 2028
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