Obesity-Related Malignant NeoplasmNCT04644224
Parent and Family Oriented Support Interventions for the Facilitation of Weight Loss in African American Families
A study testing Educational Activity, Educational Intervention and Informational Intervention in people with Obesity-Related Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Educational Activity, Educational Intervention and Informational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Peer and Family-Based Approach to Obesity in African American Families
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Obesity-Related Malignant Neoplasm
- Being tested
- Educational Activity, Educational Intervention, Informational Intervention, Questionnaire Administration, Support Group Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational ActivityOther
Attend health coaching session
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend resource navigation session
Informational InterventionOther
Receive handbook
Questionnaire AdministrationOther
Ancillary studies
Support Group TherapyProcedure or surgery
Attend support group
| Study group | Role | What they receive |
|---|---|---|
| Group I (coaching session, navigation session, support group) | Experimental | 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. Receives: Other: Educational Activity; Other: Educational Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy |
| Group II (coaching session, navigation session, support group) | Experimental | 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. Receives: Other: Educational Activity; Other: Educational Intervention; Other: Questionnaire Administration; Procedure: Support Group Therapy |
| Group III (educational handbook) | Active comparator | Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention. Receives: Other: Informational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss of parents
Will use the generalized linear mixed model (GLMM) regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Reach (Part 1 of the RE-AIM framework)
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Measured: Up to 18 months
Effectiveness (Part 2 of the RE-AIM framework)
Measured as the impact on weight loss: 6 focus groups and 15 individual interviews at 18 months to understand unanticipated outcomes; interview lay health workers (LHWs) about implementation.
Measured: Up to 18 months
Adoption (Part 3 of the RE-AIM framework)
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Measured: Up to 18 months
Implementation (Part 4 of the RE-AIM framework)
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Measured: Up to 18 months
Maintenance (Part 5 of the RE-AIM framework)
Long-term maintenance in parent/families at 18 months measured by family and church attrition, to assess church's ability to maintain employment of LHWs and their willingness to remain in this role.
Measured: Up to 18 months
Secondary outcomes (6)
Child's body mass index (BMI) z-score
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Fruit and vegetable consumption
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Physical activity
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Blood pressure
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Body fat percentage
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Waist circumference
Will use the GLMM regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start17 Jan 2019
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity-Related Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644224
- Sponsor's protocol ID
- 2017-0827
- Other IDs
- NCI-2020-07645, 2017-0827
- Status last verified
- Jul 2026
- First submitted
- 21 Oct 2020
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Peer and Family-Based Approach to Obesity in African American Families
- ClinicalTrials.gov ID
- NCT04644224
- Acronym / sponsor ID
- 2017-0827
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 81 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (coaching session, navigation session, support group) | Experimental | Other: Educational Activity, Other: Educational Intervention, Other: Questionnaire Administration, Procedure: Support Group TherapyParents/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 (coaching session, navigation session, support group) | Experimental | Other: Educational Activity, Other: Educational Intervention, Other: Questionnaire Administration, Procedure: Support Group TherapyFamilies 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 (educational handbook) | Active comparator | Other: Informational Intervention, Other: Questionnaire AdministrationFamilies whose churches are randomized to Group III, receive an educational handbook on cancer prevention. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational ActivityAttend health coaching session | Other | Group I (coaching session, navigation session, support group), Group II (coaching session, navigation session, support group) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend resource navigation session | Other | Group I (coaching session, navigation session, support group), Group II (coaching session, navigation session, support group) |
| Informational InterventionReceive handbook | Other | Group III (educational handbook) |
| Questionnaire AdministrationAncillary studies | Other | Group I (coaching session, navigation session, support group), Group II (coaching session, navigation session, support group), Group III (educational handbook) |
| Support Group TherapyAttend support group | Procedure or surgery | Group I (coaching session, navigation session, support group), Group II (coaching session, navigation session, support group) |
Primary outcome
Weight loss of parents
Time frame: Up to 18 months
Will use the generalized linear mixed model (GLMM) regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Reach (Part 1 of the RE-AIM framework)
Time frame: Up to 18 months
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
Effectiveness (Part 2 of the RE-AIM framework)
Time frame: Up to 18 months
Measured as the impact on weight loss: 6 focus groups and 15 individual interviews at 18 months to understand unanticipated outcomes; interview lay health workers (LHWs) about implementation.
Adoption (Part 3 of the RE-AIM framework)
Time frame: Up to 18 months
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Implementation (Part 4 of the RE-AIM framework)
Time frame: Up to 18 months
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Maintenance (Part 5 of the RE-AIM framework)
Time frame: Up to 18 months
Long-term maintenance in parent/families at 18 months measured by family and church attrition, to assess church's ability to maintain employment of LHWs and their willingness to remain in this role.
6 secondary outcomes
Child's body mass index (BMI) z-score
Time frame: Up to 18 months
Fruit and vegetable consumption
Time frame: Up to 18 months
Physical activity
Time frame: Up to 18 months
Blood pressure
Time frame: Up to 18 months
Body fat percentage
Time frame: Up to 18 months
Waist circumference
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna McNeill principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Activity, Educational Intervention and Informational Intervention in people with Obesity-Related Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss of parents (time frame: Up to 18 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 5 Nov 2026.