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A cluster randomised control trial of a multi-component weight management programme for adults with intellectual disabilities and obesity.
Harris, L, Hankey, C, Jones, N, Pert, C, Murray, H, Tobin, J, Boyle, S, Melville, C
The British journal of nutrition. 2017;(3):229-240
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Abstract
There have been few published controlled studies of multi-component weight management programmes that include an energy deficit diet (EDD), for adults with intellectual disabilities and obesity. The objective of this study was to conduct a single-blind, cluster randomised controlled trial comparing a multi-component weight management programme to a health education programme. Participants were randomised to either TAKE 5, which included an EDD or Waist Winners Too (WWToo), based on health education principles. Outcomes measured at baseline, 6 months (after a weight loss phase) and 12 months (after a 6-month weight maintenance phase), by a researcher blinded to treatment allocation, included: weight; BMI; waist circumference; physical activity; sedentary behaviour and health-related quality of life. The recruitment strategy was effective with fifty participants successfully recruited. Both programmes were acceptable to adults with intellectual disabilities, evidenced by high retention rates (90 %). Exploratory efficacy analysis revealed that at 12 months there was a trend for more participants in TAKE 5 (50·0 %) to achieve a clinically important weight loss of 5-10 %, in comparison to WWToo (20·8 %) (OR 3·76; 95 % CI 0·92, 15·30; 0·064). This study found that a multi-component weight management programme that included an EDD, is feasible and an acceptable approach to weight loss when tailored to meet the needs of adults with intellectual disabilities and obesity.
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Weight management for adolescents with intellectual and developmental disabilities: Rationale and design for an 18month randomized trial.
Donnelly, JE, Ptomey, LT, Goetz, JR, Sullivan, DK, Gibson, CA, Greene, JL, Lee, RH, Mayo, MS, Honas, JJ, Washburn, RA
Contemporary clinical trials. 2016;:88-95
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Abstract
Adolescents with intellectual and developmental disabilities (IDD) are an underserved group in need of weight management. However, information regarding effective weight management for this group is limited, and is based primarily on results from small, non-powered, non-randomized trials that were not conducted in accordance with current weight management guidelines. Additionally, the comparative effectiveness of emerging dietary approaches, such as portion-controlled meals (PCMs) or program delivery strategies such as video chat using tablet computers have not been evaluated. Therefore, we will conduct an 18month trial to compare weight loss (6months) and maintenance (7-18months) in 123 overweight/obese adolescents with mild to moderate IDD, and a parent, randomized to a weight management intervention delivered remotely using FaceTime™ on an iPad using either a conventional meal plan diet (RD/CD) or a Stop Light diet enhanced with PCMs (RD/eSLD), or conventional diet delivered during face-to-face home visits (FTF/CD). This design will provide an adequately powered comparison of both diet (CD vs. eSLD) and delivery strategy (FTF vs. RD). Exploratory analyses will examine the influence of behavioral session attendance, compliance with recommendations for diet (energy intake), physical activity (min/day), self-monitoring of diet and physical activity, medications, and parental variables including diet quality, physical activity, baseline weight, weight change, and beliefs and attitudes regarding diet and physical activity on both weight loss and maintenance. We will also complete a cost and contingent valuation analysis to compare costs between RD and FTF delivery.
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Improving health behaviours of Latina mothers of youths and adults with intellectual and developmental disabilities.
Magaña, S, Li, H, Miranda, E, Paradiso de Sayu, R
Journal of intellectual disability research : JIDR. 2015;(5):397-410
Abstract
BACKGROUND Latina mothers who care for children with intellectual and developmental disabilities (IDD) over the lifespan struggle to take care of their own health needs in the context of their caregiving experience. Services are typically aimed at the persons with IDD and not their family caregivers. Yet, attending to family caregiver needs may contribute to better long-term care of persons with IDD who remain at home. To address this unmet need, we developed a culturally sensitive health education intervention for Latina mothers who care for youth and adults with IDD. The aim of the intervention is to improve maternal health-related self-efficacy and health behaviours, and to reduce stress. METHOD A randomised control design was employed to determine preliminary efficacy of the intervention. Paired sample t-tests were conducted to examine within-group changes from baseline to 3-month post-test. Repeated-measures analysis of covariance was used to examine the group-by-time interaction effects. RESULTS Intervention participants showed greater increases between pre- and post-test in health-related self-efficacy; self-care, nutrition and overall health behaviours. Both groups reported decreases in depressive symptoms and caregiver burden. CONCLUSIONS While additional research is needed to determine long-term effects and to replicate findings, our results suggest that this culturally sensitive health intervention is a promising way to increase health behaviours which may lead to overall good health for Latina mothers who care for children with IDD across the lifespan.
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Training support staff to modify fluids to appropriate safe consistencies for adults with intellectual disabilities and dysphagia: an efficacy study.
Chadwick, DD, Stubbs, J, Fovargue, S, Anderson, D, Stacey, G, Tye, S
Journal of intellectual disability research : JIDR. 2014;(1):84-98
Abstract
BACKGROUND Modifying the consistency of food and drink is a strategy commonly used in the management of dysphagia for people with intellectual disabilities (ID). People with ID often depend on others for the preparation of food and drink and therefore depend on those caregivers achieving the correct consistency to keep them safe and avoid discomfort during mealtimes. Clinical experience and prior research have demonstrated that although training can improve modification, carers often find modification difficult and potentially stressful and recommend additional support for carers. Fluid consistency is often modified through the addition of powdered thickener. This study investigates the efficacy of typical training and use of consistency guides, the Thickness Indicator Model (TIM) tubes, in helping carers to modify fluids accurately. METHOD A 3 × 3 pre-post experimental design with a control group was employed to compare the observed accuracy of modification across three groups and at three time points (pre-intervention baseline, immediately post-training intervention and 3-10 months post-training). Sixty-two paid carers who supported people with ID were recruited to participate in the study and each was randomly allocated to one of the three groups: a control group given written guidance only, a group who received typical training and written guidance and a group who received training, written guidance and the TIM tubes. RESULTS & CONCLUSIONS Typical training resulted in significantly greater carer accuracy in modifying fluid consistencies when compared with written guidance alone. Use of the TIM tubes also significantly improved accuracy in the modification of drinks compared with the group who modified with the aid of written guidance alone. At 3-10-month follow-up only the group who received typical training alongside the TIM tubes were significantly more accurate than the Written Guidance group. Further research is warranted to ascertain the effectiveness of the training and the utility of the TIM tubes in improving accuracy over a longer time scale and in individuals' usual living environments.
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A multi-component universal intervention to improve diet and physical activity among adults with intellectual disabilities in community residences: a cluster randomised controlled trial.
Bergström, H, Hagströmer, M, Hagberg, J, Elinder, LS
Research in developmental disabilities. 2013;(11):3847-57
Abstract
People with ID have an increased risk for unhealthy diets, physical inactivity and weight disturbances. The aim of the current study was to investigate the effectiveness of a novel and complex intervention to improve diet and physical activity, targeting both caregivers and residents, in community residences for people with ID. A three component intervention based on Social Cognitive Theory was developed, including: (1) appointment of a health ambassador in each community residence attending network meetings, (2) a study circle for caregivers, and (3) a health course for the residents. The intervention lasted for 12-16 months and allowed for some local tailoring. A cluster randomised controlled trial, randomised at residence level, was conducted to evaluate the effects of the intervention. Thirty community residences for people with mild or moderate ID in Stockholm County, Sweden, were included. A total of 130 participants, 74 women and 56 men aged 20-66 years, entered, and 129 participants completed the study. The primary outcome was physical activity, measured by pedometry. Secondary outcomes were BMI, waist circumference, dietary quality measured by digital photography, satisfaction with life assessed with a scale, and work routines assessed with a questionnaire. Outcomes were related to intervention fidelity. A positive intervention effect was found on physical activity, with an average increase of 1608 steps/day among participants in the intervention group (P=0.045). The effect size was 0.29 (Cohen's d). The type of residence was found to be an effect moderator. A positive intervention effect was found as well on work routines, with an average increase of 7.1 percentage points on a self-assessment scale among residences in the intervention group (P=0.016). No significant effects were found on BMI, waist circumference, dietary quality, or satisfaction with life. In conclusion, this innovative intervention was effective in improving physical activity and work routines. It is likely that even greater effects could be achieved by improvements in implementation strategies, leading to higher fidelity.
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Weight management for individuals with intellectual and developmental disabilities: rationale and design for an 18 month randomized trial.
Donnelly, JE, Saunders, RR, Saunders, M, Washburn, RA, Sullivan, DK, Gibson, CA, Ptomey, LT, Goetz, JR, Honas, JJ, Betts, JL, et al
Contemporary clinical trials. 2013;(1):116-24
Abstract
Weight management for individuals with intellectual and developmental disabilities (IDD) has received limited attention. Studies on weight management in this population have been conducted over short time frames, in small samples with inadequate statistical power, infrequently used a randomized design, and have not evaluated the use of emerging effective dietary strategies such as pre-packaged meals (PMs). Low energy/fat PMs may be useful in individuals with IDD as they simplify meal planning, limit undesirable food choices, teach appropriate portion sizes, are convenient and easy to prepare, and when combined with fruits and vegetables provide a high volume, low energy dense meal. A randomized effectiveness trial will be conducted in 150 overweight/obese adults with mild to moderate IDD, and their study partners to compare weight loss (6 months) and weight maintenance (12 months) between 2 weight management approaches: 1. A Stop Light Diet enhanced with reduced energy/fat PMs (eSLD); and 2. A recommended care reduced energy/fat meal plan diet (RC). The primary aim is to compare weight loss (0-6 months) and weight maintenance (7-18 months) between the eSLD and RC diets. Secondarily, changes in chronic disease risk factors between the eSLD and RC diets including blood pressure, glucose, insulin, LDL-cholesterol, and HDL-cholesterol will be compared during both weight loss and weight maintenance. Finally, potential mediators of weight loss including energy intake, physical activity, data recording, adherence to the diet, study partner self-efficacy and daily stress related to dietary change will be explored.
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Promoting a healthy diet and physical activity in adults with intellectual disabilities living in community residences: design and evaluation of a cluster-randomized intervention.
Elinder, LS, Bergström, H, Hagberg, J, Wihlman, U, Hagströmer, M
BMC public health. 2010;:761
Abstract
BACKGROUND Many adults with intellectual disabilities have poor dietary habits, low physical activity and weight disturbances. This study protocol describes the design and evaluation of a health intervention aiming to improve diet and physical activity in this target group. In Sweden, adults with intellectual disabilities often live in community residences where the staff has insufficient education regarding the special health needs of residents. No published lifestyle interventions have simultaneously targeted both residents and staff. METHODS/DESIGN The intervention is designed to suit the ordinary work routines of community residences. It is based on social cognitive theory and takes 12-15 months to complete. The intervention includes three components: 1) Ten health education sessions for residents in their homes; 2) the appointment of a health ambassador among the staff in each residence and formation of a network; and 3) a study circle for staff in each residence. The intervention is implemented by consultation with managers, training of health educators, and coaching of health ambassadors. Fidelity is assessed based on the participation of residents and staff in the intervention activities. The study design is a cluster-randomised trial with physical activity as primary outcome objectively assessed by pedometry. Secondary outcomes are dietary quality assessed by digital photography, measured weight, height and waist circumference, and quality of life assessed by a quality of life scale. Intermediate outcomes are changes in work routines in the residences assessed by a questionnaire to managers. Adults with mild to moderate intellectual disabilities living in community residences in Stockholm County are eligible for inclusion. Multilevel analysis is used to evaluate effects on primary and secondary outcomes. The impact of the intervention on work routines in community residences is analysed by ordinal regression analysis. Barriers and facilitators of implementation are identified in an explorative qualitative study through observations and semi-structured interviews. DISCUSSION Despite several challenges it is our hope that the results from this intervention will lead to new and improved health promotion programs to the benefit of the target group. TRIAL REGISTRATION NUMBER ISRCTN33749876.