Protocol for a randomized controlled feasibility study of a coordinated parent/child weight loss intervention: Dyad Plus.
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ABSTRACT: Purpose
This paper reports on the design and conceptual framework of the Dyad Plus study, which utilizes two weight loss clinics of the Wake Forest Baptist Medical Center: Brenner Families in training (Brenner FIT®; adolescents) and By Design (adults). Dyad Plus is a coordinated program designed to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss relative to Brenner FIT alone.Methods
A total of 45 parent/adolescent dyads are randomized to one of three conditions (n = 15 for each): Brenner FIT only, Dyad (adolescent and parent both enroll simultaneously in the age appropriate program), and Dyad Plus (both parent and adolescent enroll simultaneously, but with a coordinated component for adolescent and caregiver). This study aims to develop and pilot the coordinated intervention, establish feasibility of the intervention, and determine costs associated with implementation.Results
The results of the study are expected in winter of 2021.Conclusion
If proven feasible and acceptable, Dyad Plus will be tested for effectiveness in a large-scale implementation-effectiveness clinical trial.
SUBMITTER: Dilley JR
PROVIDER: S-EPMC8078845 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesLittle is known about how children's health might be affected by parents' participation in commercial weight loss programs. Given that more than 3.2 million people subscribe to just one commercial weight loss program, Weight Watchers, any secondary effects on children's weight-related health behaviors (e.g. dietary behaviors, physical activity, and sedentary time) and body mass index from parent participation in commercial weight loss programs may have significant public health implications. This study examined the feasibility of conducting a study to assess such effects. Methods for recruitment and retention, and perceived acceptability and satisfaction among participants in small-scale preliminary study, were evaluated. Changes in body mass index and health behaviors among the parent-child dyads were also measured to test whether a larger-scale study would be warranted.MethodsThis was an 8-week, pre-post observational feasibility study involving 20 parent-child dyads where both members had overweight or obesity. Physical and behavioral data were collected at baseline and 8 weeks from both members of the dyads. Parenting data were collected at the same time periods through parents' self-report. Bivariate correlation was used to quantify the associations in changes for dyad members.ResultsFeasibility goals for retention and perceived acceptability/satisfaction among participants were met. We reached approximately 80% of our enrollment goal. Parents showed a significant decrease in body mass index of 0.53 points (p < 0.05), while children showed a significant increase in raw body mass index (0.42, p < 0.05) and body mass index percentile (0.59, p < 0.05). However, correlation between changes in parent body mass index and changes in children body mass index percentile was positively correlated (r = 0.24, p = 0.31). A decrease in parent intake of total fat was associated with a decrease in the intake of fat in their children (r = 0.47, p < 0.05).ConclusionOur findings support the viability of a larger-scale follow-up to assess the potential of using parent-only commercial weight loss program as a mechanism for improving health behaviors and body mass index in children with overweight or obesity.
| S-EPMC6170954 | biostudies-literature
Project description:ObjectiveTo examine changes in parent and child dietary intake, associations between program adherence and parent dietary changes, and the association between parent and child dietary changes in a mobile-delivered weight loss intervention for parents with personalized messaging.MethodsAdults with overweight or obesity and who had a child aged 2-12 in the home were recruited for a randomized controlled trial comparing two types of dietary monitoring: calorie monitoring (Standard, n = 37) or "red" food monitoring (Simplified, n = 35). Parents received an intervention delivered via a smartphone application with lessons, text messages, and weekly personalized feedback, and self-monitoring of diet, activity, and weight. To measure associations between parent and child dietary changes, two 24-h recalls for parents and children at baseline and 6 months measured average daily calories, percent of calories from fat, vegetables, fruit, protein, dairy, whole grains, refined grains, added sugars, percent of calories from added sugars, and total Healthy Eating Index-2015 score.ResultsHigher parent engagement was associated with lower parent percent of calories from fat, and greater days meeting the dietary goal was associated with lower parent daily calories and refined grains. Adjusting for child age, number of children in the home, parent baseline BMI, and treatment group, there were significant positive associations between parent and child daily calories, whole grains, and refined grains. Parent-child dietary associations were not moderated by treatment group.ConclusionsThese results suggest that parent dietary changes in an adult weight loss program may indirectly influence child diet.
| S-EPMC9548804 | biostudies-literature
Project description:BackgroundThis study aimed to further elucidate correlated weight changes in parent-child dyads enrolled in family-based treatment (FBT) by modeling the interdependence of weight changes during treatment.MethodsParent-child dyads (n = 172) with overweight/obesity (child mean zBMI = 2.16 ± 0.39; parent mean BMI = 37.9 ± 9.4 kg/m2 ) completed 4 months of FBT and were randomized to one of three 8-month maintenance interventions (Social Facilitation Maintenance [SFM]-high dose, SFM-low dose or control). Weight/height was measured at 0, 4 and 12 months. Structural equation models simultaneously estimated the effect that an individual had on their own (actor effect) and on one another's (partner effect) weight-status across time using the actor-partner interdependence model.ResultsActor paths were significant over time for parent and child. Partner paths were significant for child zBMI predicting parent BMI at 4 and 12 months. Maintenance condition moderated actor/partner paths in the model.ConclusionsChild weight change may motivate parents to make environmental and behavioural changes that impact their own weight.Trial registrationClinicalTrials.gov Identifier: NCT00759746.
| S-EPMC8186411 | biostudies-literature
Project description:Most parental smokers are deeply invested in their child's health, but it is unknown what factors influence parent risk perceptions of the effects of smoking on their child's health and benefits to the child of cessation.To explore differences in former versus current smokers' beliefs about harm of continuing to smoke, benefits of quitting, and how much smoking interferes with their parenting.As part of a cluster RCT to increase tobacco control in the pediatric setting, we analyzed data collected at the ten control arm practices for 24 months starting in May 2010; a cross-sectional secondary data analysis was conducted in 2013. Parents were asked about smoking status and perceived harm, benefit, and well-being related to smoking behaviors.Of the 981 enrolled smoking parents, 710 (72.4%) were contacted at 12 months. The odds of having successfully quit at 12 months was 4.12 times more likely (95% CI=1.57, 10.8) for parents who believed that quitting will benefit their children; 1.68 times more likely (95% CI=1.13, 2.51) for parents with more than a high school education; and 1.74 times greater (95% CI=1.13, 2.68) for parents with children under age 3 years. Another factor associated with having successfully quit was a prior quit attempt.Providers' smoking-cessation advice and support should begin early and underscore how cessation will benefit the health and well-being of patients' children. Additionally, parents who have recently attempted to quit may be particularly primed for another attempt.
| S-EPMC4205202 | biostudies-literature
Project description:Background:Parent-mediated early interventions (EI) for children with autism spectrum disorder (ASD) can result in significant improvements in children's cognitive ability, social functioning, behavior, and adaptive skills, as well as improvements in parental self-efficacy and treatment engagement. The common component to efficacious parent-mediated early interventions for ASD is clinician use of parent coaching and occurs when a clinician actively teaches the parent techniques to improve their child's functioning. Available evidence suggests that community-based EI clinicians rarely coach parents when working with families of these children, although specific barriers to coaching are unknown. This consistent finding points to the need to develop strategies to improve the use of parent coaching in community EI programs. The purpose of this community-partnered study is to iteratively develop and pilot test a toolkit of implementation strategies designed to increase EI clinicians' use of parent coaching. Methods:This study has four related phases. Phase 1: examine how EI clinicians trained in Project ImPACT, an evidence-based parent-mediated intervention, coach parents of children with ASD. Phase 2: identify barriers and facilitators to clinician implementation of parent coaching by administering validated questionnaires to, and conducting semi-structured interviews with, clinicians, parents, and agency leaders. Phase 3: partner with a community advisory board to iteratively develop a toolkit of implementation strategies that addresses identified barriers and capitalizes on facilitators to improve clinician implementation of evidence-based parent coaching. Phase 4: pilot test the feasibility and effectiveness of the implementation strategy toolkit in improving EI clinicians' use of parent coaching with nine EI clinicians and parent-child dyads using a multiple-baseline-across-participants single-case design. Discussion:Completion of these activities will lead to an in-depth understanding of EI clinicians' implementation of parent coaching in usual practice following training in an evidence-based parent-mediated intervention, barriers to their implementation of parent coaching, a toolkit of implementation strategies developed through an iterative community-partnered process, and preliminary evidence regarding the potential for this toolkit to improve EI clinicians' implementation of parent coaching. These pilot data will offer important direction for a larger evaluation of strategies to improve the use of parent coaching for young children with ASD.
| S-EPMC7020349 | biostudies-literature
Project description:IntroductionPreschoolers and school-aged children with congenital heart disease (CHD) are at higher risk of attention deficit hyperactivity disorder (ADHD) compared with the general population. To this day, no randomised controlled trial (RCT) aiming to improve attention has been conducted in young children with CHD. There is emerging evidence indicating that parent-child yoga interventions improve attention and reduce ADHD symptoms in both typically developing and clinical populations.Methods and analysisThis is a single-blind, two-centre, two-arm trial during which 24 children with CHD and their parents will be randomly assigned to (1) a parent-child yoga intervention in addition to standard clinical care or (2) standard clinical care alone. All participants will undergo standardised assessments: (1) at baseline, (2) immediately post-treatment and (3) 6 months post-treatment. Descriptive statistics will be used to estimate the feasibility and neurodevelopmental outcomes. This feasibility study will evaluate: (1) recruitment capacity; (2) retention, drop-out and withdrawal rates during the yoga programme and at the 6-month follow-up; (3) adherence to the intervention; (4) acceptability of the randomisation process by families; (5) heterogeneity in the delivery of the intervention between instructors and use of home-based exercises between participants; (6) proportion of missing data in the neurodevelopmental assessments and (7) SD of primary outcomes of the full RCT in order to determine the future appropriate sample size.Ethics and disseminationEthical approval has been obtained by the Research Ethics Board of the Sainte-Justine University Hospital. The findings will be disseminated in peer-reviewed journals and conferences and presented to the Canadian paediatric grand round meetings.Trial registration numberNCT05997680.
| S-EPMC10582886 | biostudies-literature
Project description:BackgroundHigh attrition following initial enrollment in evidence-based weight loss programs is a common, challenging, and under-studied issue. A behavioral economics approach consisting of modest monetary incentives may help to engage participants beyond enrollment to close the initial attrition gap.PurposeTo describe the methods and design of a pragmatic, online randomized controlled trial (RCT) of an incentivized, technology-facilitated weight loss program through an innovative research-practice partnership involving primary care, health promotion researchers, and a small business.MethodsThis study is a four-arm (1:1:1:1) RCT that compares the efficacy of outcome-based (weight loss), process-based (weighing in), a combination of outcome- and process-based, or choice-based incentives on sustaining program reach after initial enrollment for an evidence-based weight loss program. The multicomponent weight loss program includes a website, social cognitive theory-based daily health coaching, tailored messaging delivered via email and text messaging, access to online health coaches, and objective weight assessment through a community kiosk. The study will enroll 400 individuals aged 19 and older who have a body mass index ≥25 kg/m2, and have reliable access to the Internet or a smart phone. Participants will be followed for 3, 6, 9, and 12 months to assess program reach and representativeness, and continued participation after enrollment. The secondary outcomes include weight loss and program implementation costs. We will conduct participant focus groups to understand the barriers and facilitators of participation and key informant interviews focusing on clinic managers and care providers to explore the potential for future adoption and implementation of the evidence-based program.DiscussionThis study possesses the potential to close the attrition gap after initial enrollment in a web-based digital weight loss intervention in the primary care and community settings. Clinicaltrials.gov registration: NCT04225234.
| S-EPMC8040949 | biostudies-literature
Project description:BACKGROUND:Postpartum weight retention contributes to long-term weight gain and obesity for many women. Lifestyle interventions with numerous visits are logistically challenging for many postpartum women. Delivering a lifestyle intervention via social media may overcome logistic challenges to participation in in-person weight loss programs. OBJECTIVE:The objective of this study is to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups with 72 postpartum women with overweight or obesity. METHODS:Women with overweight or obesity who are 8 weeks to 12 months postpartum (N=72) will be recruited from the Hartford, Connecticut community. Eligible participants must also own an iPhone or Android smartphone and be an active Facebook user. Participants will receive a 6-month postpartum weight loss intervention based on the Diabetes Prevention Program lifestyle intervention and adapted for postpartum women. Participants will be randomized to receive the intervention via a private Facebook group or in-person group meetings. Assessments will occur at baseline, weekly during the intervention, at 6 months (at the end of the intervention), and at 12 months. Primary feasibility outcomes are recruitment, sustained participation, contamination, retention, and feasibility of assessment procedures including measurement of costs to deliver and receive the intervention. We will describe 6- and 12-month weight loss as an exploratory outcome. RESULTS:Recruitment began in September 2018. The first wave of the intervention began in February 2019, and the second wave of the intervention is expected to begin in fall 2019. We anticipate completing follow-up assessments in fall 2020, and results will be analyzed at that time. CONCLUSIONS:Results will inform the design of a large randomized controlled trial to assess whether delivering a postpartum weight loss intervention via Facebook is noninferior for weight loss and more cost-effective than delivering the intervention via traditional in-person groups. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/15530.
| S-EPMC6908979 | biostudies-literature
Project description:IntroductionIntimate partner violence detrimentally affects the social and emotional well-being of children and mothers. These two populations are impacted both individually and within the context of their relationship with one another. Child mental health, maternal mental health and the mother-child relationship may be impaired as a consequence. Early intervention to prevent or arrest impaired mother-child attachment and child development is needed. Dyadic or relational mental health interventions that include mothers with their children, such as child-parent psychotherapy, are effective in improving the mental health of both children and mothers and also strengthening their relationship. While child-parent psychotherapy has been trialled overseas in several populations, Australian research on relational interventions for children and women recovering from violence is limited. This study aims to assess the acceptability and feasibility of implementing child-parent psychotherapy in Australian families.Methods and analysisUsing a mixed methods, prepost design this feasibility study will examine the acceptability of the intervention to women with preschool aged children (3-5 years, n=15 dyads) and providers, and identify process issues including recruitment, retention and barriers to implementation and sustainability. In addition, intervention efficacy will be assessed using maternal and child health outcomes and functioning, and mother-child attachment measures. Young children's mental health needs are underserviced in Australia. More research is needed to fully understand parenting in the context of intimate partner violence and what works to help women and children recover. If the intervention is found to be feasible, findings will inform future trials and expansion of child-parent psychotherapy in Australia.Ethics and disseminationEthics approval obtained from clinical sites and the La Trobe University Human Research Ethics Committee (ID: HEC17-108). Results will be disseminated through conference proceedings and academic publications.
| S-EPMC6527992 | biostudies-literature
Project description:BackgroundBehavioral weight loss programs typically enroll 12-40 people into groups that then suffer from declining engagement over time. Web-based patient communities, on the other hand, typically offer no limits on capacity and membership is fluid. This model may be useful for boosting engagement in behavioral weight loss interventions, which could lead to better outcomes.ObjectiveIn this study, we aimed to examine the feasibility and acceptability of continuously enrolling participants into a Facebook-delivered weight loss intervention for the first 8 of 16 weeks relative to the same intervention where no new participants were enrolled after randomization.MethodsWe conducted a randomized pilot trial to compare a Facebook weight loss group that used open enrollment with a group that used closed enrollment on feasibility and acceptability in adults with BMI 27-45 kg/m2. The feasibility outcomes included retention, engagement, and diet tracking adherence. We described the percentage loss of ≥5% weight in both groups as an exploratory outcome. We also explored the relationship between total volume of activity in the group and weight loss. The participants provided feedback via web-based surveys and focus groups.ResultsRandomized participants (68/80, 85% women) were on average, aged 40.2 (SD 11.2) years with a mean BMI of 34.4 (SD 4.98) kg/m2. We enrolled an additional 54 participants (50/54, 93% female) in the open enrollment condition between weeks 1 and 8, resulting in a total group size of 94. Retention was 88% and 98% under the open and closed conditions, respectively. Randomized participants across conditions did not differ in engagement (P=.72), or diet tracking adherence (P=.42). Participant feedback in both conditions revealed that sense of community was what they liked most about the program and not enough individualized feedback was what they liked the least. Weight loss of ≥5% was achieved by 30% (12/40) of the participants randomized to the open enrollment condition and 18% (7/40) of the participants in the closed enrollment condition. Exploratory analyses revealed that the open condition (median 385, IQR 228-536.5) had a greater volume of engagement than the closed condition (median 215, IQR 145.5-292; P=.007). Furthermore, an increase of 100 in the total volume of engagement in the Facebook group each week was associated with an additional 0.1% weekly weight loss among the randomized participants (P=.02), which was independent of time, individual participant engagement, and sociodemographic characteristics.ConclusionsOpen enrollment was as feasible and acceptable as closed enrollment. A greater volume of engagement in the Facebook group was associated with weight loss, suggesting that larger groups that produce more engagement overall may be beneficial. Future research should examine the efficacy of the open enrollment approach for weight loss in a fully powered randomized trial.Trial registrationClinicalTrials.gov NCT02656680; https://clinicaltrials.gov/ct2/show/NCT02656680.
| S-EPMC9123537 | biostudies-literature