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Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial.

ABSTRACT: There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC) approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT) to examine whether these combined elements enhance intervention effectiveness. This paper describes the protocol our team is using to examine two PAC-based interventions for pediatric weight management. We hypothesize that children with obesity whose parents complete a CBT-based PAC intervention will achieve greater reductions in adiposity and improvements in cardiometabolic risk factors, lifestyle behaviours, and psychosocial outcomes than children whose parents complete a psycho-education-based PAC intervention (PEP).This study is a pragmatic, two-armed, parallel, single-blinded, superiority, randomized clinical trial. The primary objective is to examine the differential effects of a CBT-based PAC vs PEP-based PAC intervention on children's BMI z-score (primary outcome). Secondary objectives are to assess intervention-mediated changes in cardiometabolic, lifestyle, and psychosocial variables in children and parents. Both interventions are similar in frequency of contact, session duration, group facilitation, lifestyle behaviour goals, and educational content. However, the interventions differ insofar as the CBT-based intervention incorporates theory-based concepts to help parents link their thoughts, feelings, and behaviours; these cognitive activities are enabled by group leaders who possess formal training in CBT. Mothers and fathers of children (8-12?years of age; BMI ?85th percentile) are eligible to participate if they are proficient in English (written and spoken) and agree for at least one parent to attend group-based sessions on a weekly basis. Anthropometry, cardiometabolic risk factors, lifestyle behaviours, and psychosocial health of children and parents are assessed at pre-intervention, post-intervention, 6-, and 12-months follow-up.This study is designed to extend findings from earlier efficacy studies and provide data on the effect of a CBT-based PAC intervention for managing pediatric obesity in a real-world, outpatient clinical setting.ClinicalTrials.gov identifier: NCT01267097.

SUBMITTER: Ball GD

PROVIDER: S-EPMC3469386 | biostudies-literature | 2012 Aug

REPOSITORIES: biostudies-literature

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Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial.

Ball Geoff D C GD Ambler Kathryn A KA Keaschuk Rachel A RA Rosychuk Rhonda J RJ Holt Nicholas L NL Spence John C JC Jetha Mary M MM Sharma Arya M AM Newton Amanda S AS

BMC pediatrics 20120806

<h4>Background</h4>There is an urgent need to develop and evaluate weight management interventions to address childhood obesity. Recent research suggests that interventions designed for parents exclusively, which have been named parents as agents of change (PAC) approaches, have yielded positive outcomes for managing pediatric obesity. To date, no research has combined a PAC intervention approach with cognitive behavioural therapy (CBT) to examine whether these combined elements enhance interven ...[more]

PMID: 22866998

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Project description:Pediatric obesity has become increasingly prevalent over recent decades. In view of the psychosocial and physical health risks, and the high likelihood that children with obesity will grow to become adults with obesity, there is a clear need to develop evidence-based interventions that can be delivered in the health care system to optimize the health and well-being of children with obesity and their families. The aim of this paper is to describe the development, implementation, and planned evaluation of a parent-based weight management intervention designed for parents of 8-12 year olds with obesity.The principles of Intervention Mapping (IM) were used to develop an intervention called Parents as Agents of Change (PAC©). From 2006 to 2009, an environmental scan plus qualitative (individual interviews with parents and children), quantitative (medical record reviews), and literature review data were collected to gain broad insight into family factors related to pediatric obesity and its management. Theoretical frameworks and empirical evidence guided curriculum development, which was founded primarily on the tenets of family systems theory and cognitive behavioral theory. PAC was developed as a manualized, 16-session, group-based, health care professional-led intervention for parents to address individual, family, and environmental factors related to the management of pediatric obesity. The intervention was refined based on feedback from local and international experts, and has been implemented successfully in a multi-disciplinary weight management centre in a children's hospital.IM provided a practical framework to guide the systematic development of a pediatric weight management intervention for parents of children with obesity. This logical, step-by-step process blends theory and practice and is broadly applicable in the context of obesity management intervention development and evaluation. Following intervention development, the PAC intervention was evaluated within a randomized clinical trial. Trial registration NCT01267097; clinicaltrials.gov.

Project description:BackgroundImplementing evidence-based recommendations for treating pediatric overweight and obesity is challenging in low-resource settings. We conducted a randomized controlled trial to evaluate the effects of implementing the American Academy of Pediatrics overweight/obesity recommendations using a Standard Care approach alone or with the addition of an enhanced program in a safety-net pediatric primary care setting (located in Bronx, New York, United States).MethodsIn a 12-month trial, families of children (age 7-12 years; body mass index ≥85th American percentile for age and sex; 74% self-identified as Hispanic/Latino; n = 360) were randomly assigned to receive Standard Care Alone or Standard Care + Enhanced Program. An English/Spanish bilingual staff provided the Standard Care Alone consisting of quarterly semi-structured pediatrician visits targeting family-based behavioral changes. The Standard Care + Enhanced Program was enriched with eight Skill-Building Core and monthly Post-Core Support sessions.ResultsThe mean body mass index Z-score declined in both arms (P < 0.01) with no significant difference between the Standard Care Alone (0.12 kg [SE: 0.03]) and Standard Care + Enhanced Program (0.15 kg [SE: 0.03]) arm (P = 0.15). Compared to the Standard Care Alone, the Standard Care + Enhanced Program resulted in significantly greater improvements in total cholesterol (P = 0.05), low-density lipoprotein cholesterol (P = 0.04), aspartate aminotransferase (P = 0.02), and alanine transaminase (P = 0.03) concentrations.ConclusionsSafety-net primary care settings can provide efficacious pediatric weight management services. Targeted family-based behavioral counseling helps overweight/obese children achieve a modest body mass index Z-score improvement. A more intensive lifestyle intervention program may improve some metabolic parameters.Trial registrationClinicalTrials.gov Identifier: NCT00851201 . Registered 23 February 2009.

Project description:ImportanceOnline programs may help with weight loss but have not been widely implemented in routine primary care.ObjectiveTo compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.Design, setting, and participantsCluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.InterventionsParticipants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.Main outcomes and measuresThe primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.ResultsAmong the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001).Conclusions and relevanceAmong primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.Trial registrationClinicalTrials.gov Identifier: NCT02656693.

Project description:BackgroundOver recent decades, the prevalence of pediatric obesity has increased markedly in developed and developing countries, and the impact of obesity on health throughout the lifespan has led to urgent calls for action. Family-based weight management interventions that emphasize healthy lifestyle changes can lead to modest improvements in weight status of children with obesity. However, these interventions are generally short in duration, reported in the context of randomized controlled trials and there are few reports of outcomes of these treatment approaches in the clinical setting. Answering these questions is critical for improving the care of children with obesity accessing outpatient health services for weight management. In response, the CANadian Pediatric Weight management Registry (CANPWR) was designed with the following three primary aims: 1. Document changes in anthropometric, lifestyle, behavioural, and obesity-related co-morbidities in children enrolled in Canadian pediatric weight management programs over a three-year period; 2. Characterize the individual-, family-, and program-level determinants of change in anthropometric and obesity-related co-morbidities; 3. Examine the individual-, family-, and program-level determinants of program attrition.Methods/designThis prospective cohort, multi-centre study will include children (2-17 years old; body mass index ?85(th) percentile) enrolled in one of eight Canadian pediatric weight management centres. We will recruit 1,600 study participants over a three-year period. Data collection will occur at presentation and 6-, 12-, 24-, and 36-months follow-up. The primary study outcomes are BMI z-score and change in BMI z-score over time. Secondary outcomes include anthropometric (e.g., height, waist circumference,), cardiometabolic (e.g., blood pressure, lipid profile, glycemia), lifestyle (e.g., dietary intake, physical activity, sedentary activity), and psychosocial (e.g., health-related quality of life) variables. Potential determinants of change and program attrition will include individual-, family-, and program-level variables.DiscussionThis study will enable our interdisciplinary team of clinicians, researchers, and trainees to address foundational issues regarding the management of pediatric obesity in Canada. It will also serve as a harmonized, evidence-based registry and platform for conducting future intervention research, which will ultimately enhance the weight management care provided to children with obesity and their families.

Project description:BACKGROUND:During the first period of life, critically ill as well as healthy newborn infants experience recurrent painful procedures. Parents are a valuable but often overlooked resource in procedural pain management in newborns. Interventions to improve parents' knowledge and involvement in infants' pain management are essential to implement in the care of the newborn infant. Neonatal pain research has studied a range of non-pharmacological pain alleviating strategies during painful procedures, yet, regarding combined multisensorial parent-driven non-pharmacological pain management, research is still lacking. METHODS/DESIGN:A multi-center randomized controlled trial (RCT) with three parallel groups with the allocation ratio 1:1:1 is planned. The RCT "Parents as pain management in Swedish neonatal care - SWEpap", will investigate the efficacy of combined pain management with skin-to-skin contact, breastfeeding and live parental lullaby singing compared with standard pain care initiated by health care professionals, during routine metabolic screening of newborn infants (PKU-test). DISCUSSION:Parental involvement in neonatal pain management enables a range of comforting parental interventions such as skin-to-skin contact, breastfeeding, rocking and soothing vocalizations. To date, few studies have been published examining the efficacy of combined multisensorial parent-driven interventions. So far, research shows that the use of combined parent-driven pain management such as skin-to-skin contact and breastfeeding, is more effective in reducing behavioral responses to pain in infants, than using the pain-relieving interventions alone. Combined parental soothing behaviors that provide rhythmic (holding/rocking/vocalizing) or orogustatory/orotactile (feeding/pacifying) stimulation that keep the parent close to the infant, are more effective in a painful context. In the SWEpap study we also include parental live lullaby singing, which is an unexplored but promising biopsychosocial, multimodal and multisensory pain alleviating adjuvant, especially in combination with skin-to-skin contact and breastfeeding. TRIAL REGISTRATION:ClinicalTrials.gov ( NCT04341194 ) 10 April 2020.

Project description:BackgroundObesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment.Methods/designWe propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n?=?60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n?=?1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up.DiscussionTrial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide.Trial registrationCurrent Controlled Trials ISRCTN26563137.

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Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial.

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Parents as agents of change (PAC) in pediatric weight management: the protocol for the PAC randomized clinical trial.

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