OverweightWEIGHTNCT01378806
Family Partners for Health
A study testing Nutrition and exercise education and coping skills training in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and… Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Nutrition and exercise education and coping skills training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 718 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ability to speak, write, and read in English
- a BMI >25
- a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
- reside with the child; and consent to join the study
- Exclusion Criteria: Parents and children will be excluded if either has a:
- history of a heart murmur
Show all 11Show fewer
- congenital heart disease
- family history of sudden death
- history of psychological problems such as claustrophobia that would prevent participation in group classes
- participation in another clinical trial or intervention
- Asians will be excluded since there is a higher level of risk at a lower BMI than for Blacks, Hispanics, and Whites
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7460
About this study
Official title: Children and Parents Partnering Together to Manage Their Weight
Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise. Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity. The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group. Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds). Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.
- Conditions
- Overweight, Obesity
- Being tested
- Nutrition and exercise education and coping skills training
- Keywords
- overweight, obesity, adults, children
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition and exercise education and coping skills trainingBehavioural
A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own. Receives: Behavioral: Nutrition and exercise education and coping skills training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body mass index in adults and body mass index percentile in children.
Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.
Measured: Baseline to 18 months.
Secondary outcomes (3)
Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Waist circumference and triceps and subscapular skinfold measures.
Measured: Baseline to 18 months.
Change in health behaviors as measured by nutrition and exercise in adults and children.
nutrition and exercise behaviors in adults and children based on questionnaire scores.
Measured: Baseline to 18 months.
Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
eating and exercise self-efficacy in adults and children based on questionnaire scores.
Measured: Baseline 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 posted22 Jun 2011 (estimated)
- Study startApr 2007
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 718 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Investigators
- Diane C Berry, PhD, ANP-BC, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01378806
- Sponsor's protocol ID
- 07-0436
- Other IDs
- R0100254-05, 5-34696
- Acronym
- WEIGHT
- Status last verified
- Jul 2012
- First submitted
- 2 Jun 2011
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berry DC, McMurray RG, Schwartz TA, Adatorwovor R. Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States. BMC Public Health. 2018 Sep 10;18(1):1107. doi: 10.1186/s12889-018-6006-4.
PubMed 30200925Berry DC, McMurray RG, Schwartz TA, Hall EG, Neal MN, Adatorwovor R, Adatorwover R. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity. BMC Obes. 2017 Dec 4;4:39. doi: 10.1186/s40608-017-0175-z. eCollection 2017.
PubMed 29225899McMurray RG, Berry DC, Schwartz TA, Hall EG, Neal MN, Li S, Lam D. Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study. BMC Public Health. 2016 Feb 6;16:124. doi: 10.1186/s12889-016-2795-5.
PubMed 26851940Berry DC, McMurray R, Schwartz TA, Skelly A, Sanchez M, Neal M, Hall G. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study. BMC Public Health. 2012 Mar 30;12:250. doi: 10.1186/1471-2458-12-250.
PubMed 22463125
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Children and Parents Partnering Together to Manage Their Weight
- ClinicalTrials.gov ID
- NCT01378806
- Acronym / sponsor ID
- WEIGHT / 07-0436
- Conditions
- Overweight, Obesity
- Keywords
- overweight, obesity, adults, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 718 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Nursing Research (NINR)
- Study start
- Apr 2007
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 22 Jun 2011 (estimated)
- 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.
Young children who are overweight or at risk for overweight are at increased risk for becoming obese as young adults and developing type 2 diabetes and cardiovascular disease. To date, there have been no interdisciplinary interventions that targeted predominantly ethnic minority low-income children and parents and taught them to work together to improve nutrition and exercise. Using a two-group, repeated measures experimental design, this proposed study will test a 12-week intensive intervention on nutrition, exercise and coping skills (Phase I) and 9 months of continued monthly contact (Phase II) to help overweight 2nd, 3rd, and 4th grade children and their parents improve self-efficacy, health behaviors, weight status, and adiposity. The study will take this intervention to the community in which children and parents live, working with four schools in Alamance-Burlington County, NC, and four schools in Wilson County in the early evening. A total of 356 Black, Hispanic, and White children with a BMI >85th percentile and 356 parents with a BMI >25 kg/m2 will be inducted over 3 ½ years and randomized by school to either the experimental or control group. Data will be collected at Time 1 (Baseline), Time 2 (Post Phase I-Intensive Intervention), Time 3 (Post Phase II-Continued Contact), and Time 4 (6-Month Follow-Up). Data collected will include scores on the Health Promoting Lifestyle Profile II in the parents; eating self-efficacy in the children (CATCH) and parents (Eating Self-Efficacy Scale) and exercise self-efficacy in the children (CATCH) and parents (Exercise Self-Efficacy); health behaviors in the children and parents (3 Day 24-Hour Food Recall and 4 Day Accelerometry Measurement); weight status in the children (BMI percentile) and parents (BMI); and adiposity in the children and parents (waist circumference and triceps and subscapular skinfolds). Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight in children and parents is urgently needed, and helping children and parents to work together to improve their nutrition and exercise patterns by making small lifestyle pattern changes may decrease future health care costs and decrease morbidity and mortality. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Black, Hispanic, and White children and parents in other communities to assist them to manage their weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutrition and exercise education and coping skills trainingA 12-week intensive intervention on nutrition and exercise education and coping skills training (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- ability to speak, write, and read in English
- a BMI >25
- a 2nd, 3rd or 4th grade child with a BMI > 85th percentile for age and gender
- reside with the child; and consent to join the study
- history of a heart murmur
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Nutrition and exercise education and coping skills trainingA 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own. | Behavioural | Intervention |
Primary outcome
Change in body mass index in adults and body mass index percentile in children.
Time frame: Baseline to 18 months.
Height and weight measures will be taken in adults and children to calculate body mass index in adults and body mass index percentile in children.
3 secondary outcomes
Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Time frame: Baseline to 18 months.
Change in health behaviors as measured by nutrition and exercise in adults and children.
Time frame: Baseline to 18 months.
Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
Time frame: Baseline to 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
- Derived from this study: PubMed 30200925Berry DC, McMurray RG, Schwartz TA, Adatorwovor R. Benefits for African American and white low-income 7-10-year-old children and their parents taught together in a community-based weight management program in the rural southeastern United States. BMC Public Health. 2018 Sep 10;18(1):1107. doi: 10.1186/s12889-018-6006-4.
- Derived from this study: PubMed 29225899Berry DC, McMurray RG, Schwartz TA, Hall EG, Neal MN, Adatorwovor R, Adatorwover R. A cluster randomized controlled trial for child and parent weight management: children and parents randomized to the intervention group have correlated changes in adiposity. BMC Obes. 2017 Dec 4;4:39. doi: 10.1186/s40608-017-0175-z. eCollection 2017.
- Derived from this study: PubMed 26851940McMurray RG, Berry DC, Schwartz TA, Hall EG, Neal MN, Li S, Lam D. Relationships of physical activity and sedentary time in obese parent-child dyads: a cross-sectional study. BMC Public Health. 2016 Feb 6;16:124. doi: 10.1186/s12889-016-2795-5.
- Derived from this study: PubMed 22463125Berry DC, McMurray R, Schwartz TA, Skelly A, Sanchez M, Neal M, Hall G. Rationale, design, methodology and sample characteristics for the family partners for health study: a cluster randomized controlled study. BMC Public Health. 2012 Mar 30;12:250. doi: 10.1186/1471-2458-12-250.
Related trials for Overweight
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Diane C Berry, PhD, ANP-BC principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition and exercise education and coping skills training in people with Overweight and Obesity, run by University of North Carolina, Chapel Hill 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 0 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: finished, as of the sponsor's last update on 13 Jul 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in body mass index in adults and body mass index percentile in children. (time frame: Baseline to 18 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01378806, which also lists 4 linked publications.
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 13 Jul 2012.