Obesity-Related Malignant NeoplasmNCT05094466
Parent and Family Obesity Intervention in Reducing Obesity Risk in Racial Ethnic Minority Families
A study testing Behavioral Intervention, Counseling and Discussion in people with Obesity-Related Malignant Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity-Related Malignant Neoplasm
- What is being tested?
- Behavioral Intervention, Counseling and Discussion
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2019to 2 Feb 2027
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Family-Based Approach to Reducing Obesity Risk Among African American Families
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.
Read the 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.
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.
- Conditions
- Obesity-Related Malignant Neoplasm
- Being tested
- Behavioral Intervention, Counseling, Discussion, Educational Intervention, Informational Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Receive peer support sessions
CounselingOther
Also called Counseling Intervention
Receive health coaching sessions
DiscussionProcedure or surgery
Also called Discuss
Attend focus groups
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive handbook
Informational InterventionOther
Receive navigation sessions
InterviewOther
Participate in interview
| Study group | Role | What they receive |
|---|---|---|
| Arm I (parent intervention) | Experimental | 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. Receives: Behavioral: Behavioral Intervention; Other: Counseling; Procedure: Discussion; Other: Educational Intervention; Other: Informational Intervention; Other: Interview |
| Arm II (family intervention) | Experimental | 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. Receives: Behavioral: Behavioral Intervention; Other: Counseling; Procedure: Discussion; Other: Educational Intervention; Other: Informational Intervention; Other: Interview |
| Arm III (delayed comparison) | Active comparator | Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church. Receives: Procedure: Discussion; Other: Educational Intervention; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between the feasibility of the Parent and Family obesity interventions.
Measured: Up to 4 years
The correlation between the acceptability of the Parent and Family obesity interventions.
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start16 Jul 2019
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094466
- Sponsor's protocol ID
- 2017-0557
- Other IDs
- NCI-2021-09374, 2017-0557
- Status last verified
- Jul 2026
- First submitted
- 15 Sep 2021
- 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 Family-Based Approach to Reducing Obesity Risk Among African American Families
- ClinicalTrials.gov ID
- NCT05094466
- Acronym / sponsor ID
- 2017-0557
- Conditions
- Obesity-Related Malignant Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 26 Oct 2021 (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 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:
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (parent intervention) | Experimental | Behavioral: Behavioral Intervention, Other: Counseling, Procedure: Discussion, Other: Educational Intervention, Other: Informational Intervention, Other: InterviewParents 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. |
| Arm II (family intervention) | Experimental | Behavioral: Behavioral Intervention, Other: Counseling, Procedure: Discussion, Other: Educational Intervention, Other: Informational Intervention, Other: InterviewFamily 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) | Active comparator | Procedure: Discussion, Other: Educational Intervention, Other: InterviewParticipants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyReceive peer support sessions | Behavioural | Arm I (parent intervention), Arm II (family intervention) |
| CounselingAlso: Counseling InterventionReceive health coaching sessions | Other | Arm I (parent intervention), Arm II (family intervention) |
| DiscussionAlso: DiscussAttend focus groups | Procedure or surgery | Arm I (parent intervention), Arm II (family intervention), Arm III (delayed comparison) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive handbook | Other | Arm I (parent intervention), Arm II (family intervention), Arm III (delayed comparison) |
| Informational InterventionReceive navigation sessions | Other | Arm I (parent intervention), Arm II (family intervention) |
| InterviewParticipate in interview | Other | Arm I (parent intervention), Arm II (family intervention), Arm III (delayed comparison) |
Primary outcome
The correlation between the feasibility of the Parent and Family obesity interventions.
Time frame: Up to 4 years
The correlation between the acceptability of the Parent and Family obesity interventions.
Time frame: Up to 4 years
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.
- M D Anderson Cancer CenterLink 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, PhD 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 Behavioral Intervention, Counseling and Discussion 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 11 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?
The correlation between the feasibility of the Parent and Family obesity interventions. (time frame: Up to 4 years). The study lists 2 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.