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Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05094466
Recruitment Status : Recruiting
First Posted : October 26, 2021
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer.

Condition or disease Intervention/treatment Phase
Obesity-Related Malignant Neoplasm Behavioral: Behavioral Intervention Other: Counseling Procedure: Discussion Other: Educational Intervention Other: Informational Intervention Other: Interview Not Applicable

Detailed Description:

PRIMARY OBJECTIVE:

I. Establish the feasibility and acceptability of the Parent and Family obesity interventions.

SECONDARY OBJECTIVES:

I. Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities.

II. Explore the preliminary impact of the Parent and Family interventions on behavioral, social and environmental outcomes in parent/child dyads. III. Explore potential mediators (self-efficacy, perceived stress, depressive symptoms) and moderators (sex of dyads, family history of lifestyle changes, and church attendance).

OUTLINE: Churches are randomized to 1 of 3 arms.

ARM I (PARENT INTERVENTION): Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay health worker (LHW) monthly for 6 months and church-based peer support monthly for 6 months.

ARM II (FAMILY INTERVENTION): Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

ARM III (DELAYED COMPARISON): Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Family-Based Approach to Reducing Obesity Risk Among African American Families
Actual Study Start Date : July 16, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arm Intervention/treatment
Experimental: Arm I (parent intervention)
Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.
Behavioral: Behavioral Intervention
Receive peer support sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

Other: Counseling
Receive health coaching sessions
Other Name: Counseling Intervention

Procedure: Discussion
Attend focus groups
Other Name: Discuss

Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Informational Intervention
Receive navigation sessions

Other: Interview
Participate in interview

Experimental: Arm II (family intervention)
Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.
Behavioral: Behavioral Intervention
Receive peer support sessions
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

Other: Counseling
Receive health coaching sessions
Other Name: Counseling Intervention

Procedure: Discussion
Attend focus groups
Other Name: Discuss

Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Informational Intervention
Receive navigation sessions

Other: Interview
Participate in interview

Active Comparator: Arm III (delayed comparison)
Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.
Procedure: Discussion
Attend focus groups
Other Name: Discuss

Other: Educational Intervention
Receive handbook
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Other: Interview
Participate in interview




Primary Outcome Measures :
  1. The correlation between the feasibility of the Parent and Family obesity interventions. [ Time Frame: Up to 4 years ]
  2. The correlation between the acceptability of the Parent and Family obesity interventions. [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ELIGIBLE IN-DEPTH INTERVIEW PARTICIPANTS: Any church leader, such as pastors, minister, church secretary, health ministry leader, youth leader, deacons, ministry leader, director
  • PARENT-CHILD DYADS: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
  • PARENT-CHILD DYADS: Live together in the same household
  • PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic)
  • PARENTS/CAREGIVERS: Parent or caregiver age 18 through 65 years old
  • PARENTS/CAREGIVERS: Are obese (body mass index [BMI] >= 30)
  • PARENTS/CAREGIVERS: Are not currently participating in a physical activity (PA), diet, or weight management program
  • PARENTS/CAREGIVERS: Enroll with a child aged 10-16 years
  • PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access
  • PARENTS/CAREGIVERS: Are able to speak, read, and write in English
  • CHILDREN: They are aged between 10-16 years

Exclusion Criteria:

  • PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period
  • PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire
  • PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05094466


Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lorna McNeill    713-563-1103    lmcneill@mdanderson.org   
Principal Investigator: Lorna McNeill         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Lorna McNeill M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT05094466    
Other Study ID Numbers: 2017-0557
NCI-2021-09374 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0557 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 26, 2021    Key Record Dates
Last Update Posted: August 24, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight