Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- Establish the feasibility and acceptability of the Parent and Family obesity interventions.
SECONDARY OBJECTIVES:
-
Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities.
-
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.
Study Design
Arms and Interventions
| 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:
Other: Counseling
Receive health coaching sessions
Other Names:
Procedure: Discussion
Attend focus groups
Other Names:
Other: Educational Intervention
Receive handbook
Other Names:
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:
Other: Counseling
Receive health coaching sessions
Other Names:
Procedure: Discussion
Attend focus groups
Other Names:
Other: Educational Intervention
Receive handbook
Other Names:
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 Names:
Other: Educational Intervention
Receive handbook
Other Names:
Other: Interview
Participate in interview
|
Outcome Measures
Primary Outcome Measures
- The correlation between the feasibility of the Parent and Family obesity interventions. [Up to 4 years]
- The correlation between the acceptability of the Parent and Family obesity interventions. [Up to 4 years]
Eligibility Criteria
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
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PARENT-CHILD DYADS: Live together in the same household
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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
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PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Lorna McNeill, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2017-0557
- NCI-2021-09374
- 2017-0557