Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families

NCT ID: NCT04644224

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2028-12-31

Brief Summary

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This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families.

Detailed Description

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PRIMARY OBJECTIVES:

I. Determine whether a parent/caregiver intervention or a family intervention can produce greater weight loss among obese African American (AA) parents at 12 months compared to a cancer prevention group (control).

II. Use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model, to evaluate individual and church-level barriers and facilitators on program reach, effectiveness, adoption, implementation, maintenance and dissemination.

SECONDARY OBJECTIVES:

I. Explore whether a parent/caregiver intervention and a family intervention can produce weight maintenance or weight loss, as determined by change in body mass index (BMI) z-score, among AA children at risk for obesity at 12 months compared to the control group.

II. Determine the extent to which the proposed interventions improve fruit and vegetable (FV) consumption, physical activity, blood pressure, body fat percentage, muscle mass and waist circumference.

OUTLINE: Churches are randomized to 1 of 3 groups.

GROUP I: 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 II: 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 III: Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Conditions

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Obesity-Related Malignant Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I (coaching session, navigation session, support group)

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 Type EXPERIMENTAL

Educational Activity

Intervention Type OTHER

Attend health coaching session

Educational Intervention

Intervention Type OTHER

Attend resource navigation session

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Support Group Therapy

Intervention Type PROCEDURE

Attend support group

Group II (coaching session, navigation session, support group)

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 Type EXPERIMENTAL

Educational Activity

Intervention Type OTHER

Attend health coaching session

Educational Intervention

Intervention Type OTHER

Attend resource navigation session

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Support Group Therapy

Intervention Type PROCEDURE

Attend support group

Group III (educational handbook)

Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive handbook

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Educational Activity

Attend health coaching session

Intervention Type OTHER

Educational Intervention

Attend resource navigation session

Intervention Type OTHER

Informational Intervention

Receive handbook

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Support Group Therapy

Attend support group

Intervention Type PROCEDURE

Other Intervention Names

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Education for Intervention Intervention by Education Intervention through Education Intervention, Educational

Eligibility Criteria

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Inclusion Criteria

* DYAD: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
* DYAD: Live together in the same household
* PARENT/CAREGIVER: Self-identify as a racial ethic minority (i.e., black or African American or Hispanic)
* PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
* PARENT/CAREGIVER: Are overweight (BMI greater than or equal to 25);
* 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 8-17 years
* PARENT/CAREGIVER: Are able to speak English

Exclusion Criteria

* PARENT/CAREGIVER: They are currently pregnant or thinking about becoming pregnant during the study period
* PARENT/CAREGIVER: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire plus (PAR-Q +)


1\) None.
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lorna McNeill

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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M D Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2020-07645

Identifier Type: REGISTRY

Identifier Source: secondary_id

2017-0827

Identifier Type: OTHER

Identifier Source: secondary_id

2017-0827

Identifier Type: -

Identifier Source: org_study_id

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