Clinical trial NCT05094466: Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families
Official title: A Family-Based Approach to Reducing Obesity Risk Among African American Families
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity-Related Malignant Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: The correlation between the feasibility of the Parent and Family obesity interventions.
timeFrame: Up to 4 years
measure: The correlation between the acceptability of the Parent and Family obesity interventions.
timeFrame: Up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lorna McNeill, PhD
role: PRINCIPAL_INVESTIGATOR
References: