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The family partners for health study: a cluster randomized controlled trial for child and parent weight management.

ABSTRACT: The purpose of this study was to test a two-phased nutrition and exercise education, coping skills training, and exercise intervention program for overweight or obese low-income ethnic minority 2nd to 4th grade children and their parents in rural North Carolina, USA.A cluster randomized controlled trial was carried out with 358 children (7-10 years) and a parent for each child (n=358). General linear mixed models were used to determine the effects of the intervention on weight, adiposity, health behaviors, and eating and exercise self-efficacy by examining changes in children and parents from baseline to completion of the study (18 months).At 18 months, children in the experimental group did not have a significantly decreased body mass index (BMI) percentile (P=0.470); however, they showed a reduction in the growth rate of their triceps (P=0.001) and subscapular skinfolds (P<0.001) and an improvement in dietary knowledge (P=0.018) and drank less than one glass of soda per day (P=0.052) compared with the control group. Parents in the experimental group had decreased BMI (P=0.001), triceps (P<0.001) and subscapular skinfolds (P<0.001) and increased nutrition (P=0.003) and exercise (P<0.001) knowledge and more often drank water or unsweetened drinks (P=0.029). At 18 months, children in the experimental group did not show significant improvement in eating (P=0.956) or exercise self-efficacy (P=0.976). Experimental parents demonstrated improved socially acceptable eating self-efficacy (P=0.013); however, they did not show significant improvement in self-efficacy pertaining to emotional eating (P=0.155) and exercise (P=0.680).The results suggest that inclusion of children and parents in the same intervention program is an effective way to decrease adiposity and improve nutrition behaviors in both children and parents and improve weight and eating self-efficacy in parents.

SUBMITTER: Berry DC

PROVIDER: S-EPMC3904082 | biostudies-other | 2014 Jan

REPOSITORIES: biostudies-other

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The family partners for health study: a cluster randomized controlled trial for child and parent weight management.

Berry D C DC Schwartz T A TA McMurray R G RG Skelly A H AH Neal M M Hall E G EG Aimyong N N Amatuli D J DJ Melkus G G

Nutrition & diabetes 20140113

<h4>Objective</h4>The purpose of this study was to test a two-phased nutrition and exercise education, coping skills training, and exercise intervention program for overweight or obese low-income ethnic minority 2nd to 4th grade children and their parents in rural North Carolina, USA.<h4>Methods</h4>A cluster randomized controlled trial was carried out with 358 children (7-10 years) and a parent for each child (n=358). General linear mixed models were used to determine the effects of the interve ...[more]

PMID: 24418827

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Project description:BackgroundCommunity-based programmes for children with excess weight are widely available, but few have been developed to meet the needs of culturally diverse populations. We adapted an existing children's weight management programme, focusing on Pakistani and Bangladeshi communities. We report the evaluation of this programme to assess feasibility of programme delivery, acceptability of the programme to participants from diverse communities, and feasibility of methods to inform a future trial.MethodsA cluster-randomised feasibility trial was undertaken in a large UK city. Children's weight management programmes (n?=?24) were randomised to be delivered as the adapted or the standard programme (2:1 ratio). Routine data on participant attendance (n?=?243) at the sessions were used to estimate the proportion of families completing the adapted and standard programmes (to indicate programme acceptability). Families planning to attend the programmes were recruited to participate in the feasibility study (n?=?92). Outcome data were collected from children and parents at baseline, end of programme, and 6 months post-programme. A subsample (n?=?24) of those attending the adapted programme participated in interviews to gain their views of the content and delivery and assess programme acceptability. Feasibility of programme delivery was assessed through observation and consultation with facilitators, and data on costs were collected.ResultsThe proportion of Pakistani and Bangladeshi families and families of all ethnicities completing the adapted programme was similar: 78.8% (95% CI 64.8-88.2%) and 76.3% (95% CI 67.0-83.6%) respectively. OR for completion of adapted vs. standard programme was 2.40 (95% CI 1.32-4.34, p?=?0.004). The programme was feasible to deliver with some refinements, and participant interview data showed that the programme was well received. Study participant recruitment was successful, but attrition was high (35% at 6 months). Data collection was mostly feasible, but participant burden was high. Data collection on cost of programme delivery was feasible, but costs to families were more challenging to capture.ConclusionsThis culturally adapted programme was feasible to deliver and highly acceptable to participants, with increased completion rates compared with the standard programme. Consideration should be given to a future trial to evaluate its clinical and cost-effectiveness.Trial registrationISRCTN81798055, registered: 13/05/2014.

Project description:BackgroundThere are major gaps in the management of pediatric tuberculosis (TB) contact investigation for rapid identification of active tuberculosis and initiation of preventive therapy. This study aims to evaluate the impact of a community-based intervention as compared to facility-based model for the management of children in contact with bacteriologically confirmed pulmonary TB adults in low-resource high-burden settings.Methods/designThis multicenter parallel open-label cluster randomized controlled trial is composed of three phases: I, baseline phase in which retrospective data are collected, quality of data recording in facility registers is checked, and expected acceptability and feasibility of the intervention is assessed; II, intervention phase with enrolment of index cases and contact cases in either facility- or community-based models; and III, explanatory phase including endpoint data analysis, cost-effectiveness analysis, and post-intervention acceptability assessment by healthcare providers and beneficiaries. The study uses both quantitative and qualitative analysis methods. The community-based intervention includes identification and screening of all household contacts, referral of contacts with TB-suggestive symptoms to the facility for investigation, and household initiation of preventive therapy with follow-up of eligible child contacts by community healthcare workers, i.e., all young (< 5 years) child contacts or older (5-14 years) child contacts living with HIV, and with no evidence of TB disease. Twenty clusters representing TB diagnostic and treatment facilities with their catchment areas are randomized in a 1:1 ratio to either the community-based intervention arm or the facility-based standard of care arm in Cameroon and Uganda. Randomization was stratified by country and constrained on the number of index cases per cluster. The primary endpoint is the proportion of eligible child contacts who initiate and complete the preventive therapy. The sample size is of 1500 child contacts to identify a 10% difference between the arms with the assumption that 60% of children will complete the preventive therapy in the standard of care arm.DiscussionThis study will provide evidence of the impact of a community-based intervention on household child contact screening and management of TB preventive therapy in order to improve care and prevention of childhood TB in low-resource high-burden settings.Trial registrationClinicalTrials.gov NCT03832023 . Registered on 6 February 2019.

Project description:BackgroundThe Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) intervention was created as a team-based approach to well-child care (WCC) that relies on a health educator (Parent Coach) to provide the bulk of WCC services, address specific needs faced by families in low-income communities, and decrease reliance on the clinician as the primary provider of WCC services.ObjectiveThis study aims to evaluate the impact of PARENT using a cluster randomized controlled trial.MethodsThis study tested the effectiveness of PARENT at 10 clinical sites in 2 federally qualified health centers in Tacoma, Washington, and Los Angeles, California. We conducted a cluster randomized controlled trial that included 916 families with children aged ≤12 months at the time of the baseline survey. Parents will be followed up at 6 and 12 months after enrollment. The Parent Coach, the main element of PARENT, provides anticipatory guidance, psychosocial screening and referral, developmental and behavioral surveillance, screening, and guidance at each WCC visit. The coach is supported by parent-focused previsit screening and visit prioritization, a brief, problem-focused clinician encounter for a physical examination and any concerns that require a clinician's attention, and an automated text message parent reminder and education service for periodic, age-specific messages to reinforce key health-related information recommended by Bright Futures national guidelines. We will examine parent-reported quality of care (receipt of nationally recommended WCC services, family-centeredness of care, and parental experiences of care), and health care use (WCC, urgent care, emergency department, and hospitalizations), conduct a cost analysis, and conduct a separate time-motion study of clinician time allocation to assess efficiency. We will also collect data on exploratory measures of parent-and parenting-focused outcomes. Our primary outcomes were receipt of anticipatory guidance and emergency department use.ResultsParticipant recruitment began in March 2019. After recruitment, 6- and 12-month follow-up surveys will be completed. As of August 30, 2021, we enrolled a total of 916 participants.ConclusionsThis large pragmatic trial of PARENT in partnership with federally qualified health centers will assess its utility as an evidence-based and financially sustainable model for the delivery of preventive care services to children in low-income communities.Trial registrationClinicalTrials.gov: NCT03797898; https://clinicaltrials.gov/ct2/show/NCT03797898.International registered report identifier (irrid)DERR1-10.2196/27054.

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The family partners for health study: a cluster randomized controlled trial for child and parent weight management.

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The family partners for health study: a cluster randomized controlled trial for child and parent weight management.

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