Family Partners for Health (WEIGHT)
12 juli 2012 bijgewerkt door: University of North Carolina, Chapel Hill
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
718
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599-7460
- The University of North Carolina at Chapel Hill
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
7 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria: Inclusion criteria for children include:
- ability to speak, write, and read in English
- a BMI > 85th percentile for age and gender
- at least one parent or guardian with a BMI >25
- assent and their parent or guardian's consent to their participation
Inclusion criteria for parents or guardians include:
- 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
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Intervention
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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in body mass index in adults and body mass index percentile in children.
Tijdsspanne: Baseline to 18 months.
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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.
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Baseline to 18 months.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in adiposity for adults and children as measured by change in waist circumference, triceps, and subscapular skinfold measures.
Tijdsspanne: Baseline to 18 months.
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Waist circumference and triceps and subscapular skinfold measures.
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Baseline to 18 months.
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Change in health behaviors as measured by nutrition and exercise in adults and children.
Tijdsspanne: Baseline to 18 months.
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nutrition and exercise behaviors in adults and children based on questionnaire scores.
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Baseline to 18 months.
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Change in self-efficacy in adults and children as measured by belief that they can improve their eating and exercise behaviors.
Tijdsspanne: Baseline to 18 months.
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eating and exercise self-efficacy in adults and children based on questionnaire scores.
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Baseline to 18 months.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Diane C Berry, PhD, ANP-BC, University of North Carolina, Chapel Hill
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- Berry 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. Erratum In: BMC Obes. 2018 Jan 26;5:3. Adatorwover R [corrected to Adatorwovor R].
- McMurray 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.
- Berry 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2007
Primaire voltooiing (Werkelijk)
1 oktober 2011
Studie voltooiing (Werkelijk)
1 oktober 2011
Studieregistratiedata
Eerst ingediend
2 juni 2011
Eerst ingediend dat voldeed aan de QC-criteria
20 juni 2011
Eerst geplaatst (Schatting)
22 juni 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
13 juli 2012
Laatste update ingediend die voldeed aan QC-criteria
12 juli 2012
Laatst geverifieerd
1 juli 2012
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 07-0436
- R0100254-05 (Ander subsidie-/financieringsnummer: NINR)
- 5-34696 (Andere identificatie: The University of North Carolina at Chapel)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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