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      Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT

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          Abstract

          Objective

          To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT).

          Design

          A two-arm, randomised feasibility trial with a mixed-methods process evaluation.

          Setting

          Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.

          Participants

          Fathers with overweight or obesity and their children aged 4–11 years.

          Intervention

          Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.

          Outcomes

          Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews.

          Results

          The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m 2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as ‘good/very good’ and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI −5.1 to −0.6).

          Conclusions

          The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop–go criteria.

          Trial registration number

          ISRCTN16724454.

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          Most cited references16

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          Assessing the performance of a new generic measure of health-related quality of life for children and refining it for use in health state valuation.

          Previous research to develop a new generic paediatric health-related quality of life (HR-QOL) measure generated 11 dimensions of HR-QOL, covering physical, emotional and social functioning. These dimensions and their response scales were developed from interviews with children. Some of these dimensions have alternative wording choices. The measure is intended to be preference based so that it can be used in paediatric economic evaluation. The aims of this research were to assess the performance of this new descriptive system in a general and clinical paediatric population, to determine the most appropriate wording for the dimensions and to refine the descriptive system to be amenable to health state valuation to make it suitable for use in economic evaluation. A sample of 247 children was recruited from general and clinical paediatric populations. Each child completed the descriptive system and data were collected to allow assessment of practicality (including response rates, completion rates and time to complete), content, face and construct validity, whether the child could self-complete and preferences for alternative wordings that could be used for dimensions. These data were used to inform the final choice of wording for dimensions, the scales used for each dimension and the reduction of dimensions to meet the constraints of health state valuation. The descriptive system demonstrated good practicality and validity in both the general and clinical paediatric samples. The completion rates were excellent (>98%), the mean time to complete was low (3.8 minutes for the general and 5.3 minutes for the clinical sample) and there was evidence of face, content and construct validity. The descriptive system was able to demonstrate significant differences between the general and clinical samples and according to the level of health of children. 96% of the school sample and 85% of the clinical sample were able to self-complete. The final choice of wording for the 11 dimensions was determined by the preferences and comments of the children. To make it amenable for health state valuation, the number of dimensions was reduced from 11 to 9 by removing the dimensions 'jealous' and 'embarrassed'. The descriptive system performed well in both the general and the clinical populations, and the final descriptive system generates health states that are feasible for health state valuation. Further research is needed to value the final descriptive system by obtaining preference weights for each health state, thereby making the measure suitable for use in paediatric economic evaluation.
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            Working with children to develop dimensions for a preference-based, generic, pediatric, health-related quality-of-life measure.

            K Stevens (2010)
            Use of preference-based measures (PBM) of health-related quality of life (HRQoL) is increasing. PBMs allow the calculation of quality-adjusted life years, which can be used in decision making. Research in the field of pediatric PBMs is lacking. This work is the first stage in the development of a new generic, pediatric PBM of HRQoL. Seventy-four qualitative interviews were undertaken with children to find out how health affects their lives. Sampling was purposive, balancing primarily for health within age, with gender and ethnicity as secondary criteria. Interviews covered a wide range of health conditions, and children were successfully able to articulate how their health affected their lives. Eleven dimensions of HRQoL were identified, covering social, emotional, and physical aspects, in common with other generic pediatric HRQoL measures, but differ by including feeling jeal'ous and feeling tired/weak and not including dimensions related to parental, family, or behavioral issues.
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              The 'Healthy Dads, Healthy Kids' community randomized controlled trial: a community-based healthy lifestyle program for fathers and their children.

              To evaluate the effectiveness of the 'Healthy Dads, Healthy Kids (HDHK)' program when delivered by trained facilitators in community settings. A two-arm randomized controlled trial of 93 overweight/obese fathers (mean [SD] age=40.3 [5.3] years; BMI=32.5 [3.8] kg/m(2)) and their primary school-aged children (n=132) from the Hunter Region, Australia. In 2010-2011, families were randomized to either: (i) HDHK intervention (n=48 fathers, n=72 children) or (ii) wait-list control group. The 7-week intervention included seven sessions and resources (booklets, pedometers). Assessments were held at baseline and 14-weeks with fathers' weight (kg) as the primary outcome. Secondary outcomes for fathers and children included waist, BMI, blood pressure, resting heart rate, physical activity (pedometry), and self-reported dietary intake and sedentary behaviors. Linear mixed models (intention-to-treat) revealed significant between-group differences for fathers' weight (P<.001, d=0.24), with HDHK fathers losing more weight (-3.3 kg; 95%CI, -4.3, -2.4) than control fathers (0.1 kg; 95%CI, -0.9,1.0). Significant treatment effects (P<.05) were also found for fathers' waist (d=0.41), BMI (d=0.26), resting heart rate (d=0.59), energy intake (d=0.49) and physical activity (d=0.46) and for children's physical activity (d=0.50) and adiposity (d=0.07). HDHK significantly improved health outcomes and behaviors in fathers and children, providing evidence for program effectiveness when delivered in a community setting. Copyright © 2013. Published by Elsevier Inc.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                10 December 2019
                : 9
                : 12
                : e033534
                Affiliations
                [1 ] departmentDepartment of Health , University of Bath , Bath, Somerset, UK
                [2 ] departmentBirmingham Clinical Trials Unit (BCTU) , University of Birmingham , Birmingham, UK
                [3 ] departmentHealth Services Management Centre , University of Birmingham , Birmingham, UK
                [4 ] departmentInstitute of Applied Health Research , University of Birmingham , Birmingham, UK
                [5 ] Fatherhood Institute , Marlborough, Wiltshire, UK
                [6 ] departmentSchool of Health Sciences , University of Newcastle , Callaghan, New South Wales, Australia
                [7 ] departmentSchool of Sport, Exercise and Health Sciences , Loughborough University , Loughborough, UK
                [8 ] Public member , Leamington Spa, Warwickshire, UK
                [9 ] departmentHealth Economics Unit, Institute of Applied Health Research , University of Birmingham , Birmingham, UK
                [10 ] departmentCancer Research UK Clinical Trials Unit , University of Birmingham , Birmingham, UK
                [11 ] Birmingham Community Healthcare NHS Trust , Aston, Birmingham, UK
                [12 ] departmentSchool of Education , University of Newcastle , Callaghan, New South Wales, Australia
                Author notes
                [Correspondence to ] Professor Kate Jolly; c.b.jolly@ 123456bham.ac.uk
                Author information
                http://orcid.org/0000-0002-4018-3855
                Article
                bmjopen-2019-033534
                10.1136/bmjopen-2019-033534
                6924741
                31826896
                be2ea723-c833-4431-96c3-cb9421a5f899
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See:  https://creativecommons.org/licenses/by/4.0/.

                History
                : 09 August 2019
                : 03 October 2019
                : 01 November 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001921, Public Health Research Programme;
                Award ID: 14/185/13
                Categories
                Public Health
                Original Research
                1506
                1724
                Custom metadata
                unlocked

                Medicine
                feasibility studies,fathers,weight loss,healthy lifestyle
                Medicine
                feasibility studies, fathers, weight loss, healthy lifestyle

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