Remote delivery of weight management for adults with intellectual and developmental disabilities: Rationale and design for a 24?month randomized trial.
ABSTRACT: Adults with intellectual and developmental disabilities (IDD) represent an underserved segment of the US population with a high prevalence of obesity and limited options for weight management. Previous research has demonstrated clinically meaningful weight loss of 7% of total body weight in in adults with IDD using an enhanced Stop Light Diet (eSLD) in combination with monthly at-home face-to-face (FTF) behavioral sessions, and a recommendation for increased physical activity. However, the time and cost associated with FTF delivery (travel + sessions) limits the potential for scaling and implementation and suggests the need for the evaluation of less costly and burdensome strategies for intervention delivery. Therefore, we will conduct a 24-mo. randomized trial to compare a weight management intervention (6 mos. weight loss, 12 mos. maintenance, 6 mos. no-contact follow-up) delivered to 120 overweight/obese adults with IDD in their home, either remotely (RD) using video conferencing on a tablet computer, or during FTF visits. Our primary aim is whether RD is non-inferior to FTF for weight loss (0-6 mos.). Secondarily, we will compare the RD and FTF groups on mean weight loss, the proportion of participants who achieve clinically meaningful weight loss, and changes in quality of life across 24?months. We will also conduct cost analysis, cost-effectiveness, and contingent valuation analyses to compare the RD and FTF groups.
Project description:Face-to-face (FTF) weight management is costly and presents barriers for individuals seeking treatment; thus, alternate delivery systems are needed. The objective of this study was to compare weight management delivered by FTF clinic or group conference calls (phone).Randomized equivalency trial in 295 overweight/obese men/women (BMI = 35.1±4.9, Age = 43.8±10.2, Minority = 39.8%). Weight loss (0-6 months) was achieved by reducing energy intake between 1,200 and 1,500 kcal/day and progressing physical activity (PA) to 300 min/week. Weight maintenance (7-18 months) provided adequate energy to maintain weight and continued 300 min/week of PA. Behavioral weight management strategies were delivered weekly for 6 months and gradually reduced during 7-18 months. A cost analysis provided a comparison of expenses between groups.Weight change from baseline to 6 months was -13.4 ± 6.7% and -12.3 ± 7.0% for FTF clinic and phone, respectively. Weight change from 6-18 months was 6.4 ± 7.0% and 6.4 ± 5.2%, for FTF clinic and phone, respectively. The cost to FTF participants was $789.58 more per person.Phone delivery provided equivalent weight loss and maintenance and reduced program cost. Ubiquitous access to phones provides a vast reach for this approach.
Project description:Adolescents with intellectual and developmental disabilities (IDD) are less physically active and have lower cardiovascular fitness compared with their typically developing peers. This population faces additional barriers to participation in moderate-to-vigorous physical activity (MVPA) such as reliance on parents, lack of peer-support, and lack of inclusive physical activity opportunities. Previous interventions to increase MVPA in adolescents with IDD have met with limited success, at least in part due to requiring parents to transport their adolescent to an exercise facility. We recently developed a remote system to deliver MVPA to groups of adolescents with IDD in their homes via video conferencing on a tablet computer. This approach eliminates the need for transportation and provides social interaction and support from both a health coach and other participants. We will conduct a 18-mo. trial (6 mos. active, 6 mos. maintenance, 6 mos. no-contact follow-up) to compare changes in objectively assessed MVPA in 114 adolescents with IDD randomized to a single level intervention delivered only to the adolescent (AO) or a multi-level intervention delivered to both the adolescent and a parent (A?+?P). Our primary aim is to compare increases in MVPA (min/d) between the AO and A?+?P groups from 0 to 6 mos. Secondarily we will compare changes in MVPA, sedentary time, cardiovascular fitness, muscular strength, motor ability, quality of life, and the percentage of adolescents achieving the US recommendation of 60?min. MVPA/d across 18 mos. We will also explore the influence of process variables/participant characteristics on changes in MVPA across 18 mos. NCT registration: NCT03684512.
Project description:To compare three interventions to reduce diabetes distress (DD) and improve self-management among non-clinically depressed adults with type 2 diabetes mellitus (T2DM).In REDEEM, 392 adults with T2DM and DD were randomized to computer-assisted self-management (CASM), CASM plus DD-specific problem solving (CAPS), or a computer-administered minimal supportive intervention. Primary outcomes were Diabetes Distress Scale (DDS) total, the Emotional Burden (EB) and Regimen Distress (RD) DDS subscales, and diet, exercise, and medication adherence.Significant and clinically meaningful reductions in DD (DDS, EB, and RD) and self-management behaviors occurred in all three conditions (P < 0.001), with no significant between-group differences. There was, however, a significant group × baseline distress interaction (P < 0.02), in which patients with high baseline RD in the CAPS condition displayed significantly larger RD reductions than those in the other two conditions. RD generated the most distress and displayed the greatest distress reduction as a result of intervention. The pace of DD reduction varied by patient age: older patients demonstrated significant reductions in DD early in the intervention, whereas younger adults displayed similar reductions later. Reductions in DD were accompanied by significant improvements in healthy eating, physical activity, and medication adherence, although not by change in HbA1c.DD is malleable and highly responsive to intervention. Interventions that enhance self-management also reduce DD significantly, but DD-specific interventions may be necessary for patients with high initial levels of DD. Future research should identify the minimal, most cost-effective interventions to reduce DD and improve self-management.
Project description:Rural adults have a higher risk of developing obesity than urban adults. Several evidence-based interventions have targeted rural regions, but their impact, defined as reach (number and representativeness of participants) by effectiveness, has not been examined. The purpose of this review was to determine the impact of rural weight loss interventions and the availability of data across dimensions of the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework. A systematic review was conducted to identify rural weight loss interventions that targeted adults. RE-AIM-related data were abstracted from each article. We performed a meta-analysis to examine effectiveness. Sixty-four articles reported on rural weight loss interventions, describing 50 unique interventions. The median number of participants was 107. Median participation rate differed between values reported by the authors (62%) and values computed using a standard method (32%). Two studies reported on sample representativeness; none reported comparisons made between target and actual delivery settings. Median weight loss per participant was 3.64 kg. Meta-analyses revealed the interventions achieved a significant weight reduction, and longer-duration interventions resulted in greater weight loss. Rural weight loss interventions appear to be effective in supporting clinically meaningful weight loss but reach and cost outcomes are still difficult to determine.
Project description:BACKGROUND:Attention-deficit hyperactivity disorder and autism are increasingly recognised in adults. For a diagnostic evaluation, parental information on childhood development is needed. However, no instruments that retrospectively describe neurodevelopmental problems in childhood are validated for evaluating adults. The 181-item parent-report questionnaire Five to Fifteen (FTF) is nevertheless frequently used for assessments in adulthood. AIMS:To examine if FTF is reliable for obtaining retrospective neurodevelopmental history among young adults. METHOD:Details of parents who had assessed their children with the FTF for neuropsychiatric evaluation were retrieved and they were asked to complete the FTF again 10-19 years later. Agreements between original and retrospective scorings were analysed. RESULTS:Long-term reliability for FTF varies considerably between individual items. Several difficulties are reported as more severe at the retrospective scoring than at the original scoring. A selection of 24 items (FTF-Brief) with good agreement over time, is presented for use in adult psychiatry settings. CONCLUSION:Neuropsychiatric symptoms may fluctuate over time and become more prominent when demands increase. Informants' recollections of their child's neurodevelopmental symptoms may be a selection of symptoms that are longstanding rather than present at a specific age in childhood. DECLARATION OF INTEREST:None.
Project description:Fructosyltransferase (FTF) enzymes produce fructose polymers (fructans) from sucrose. Here, we report the isolation and characterization of an FTF-encoding gene from Lactobacillus reuteri strain 121. A C-terminally truncated version of the ftf gene was successfully expressed in Escherichia coli. When incubated with sucrose, the purified recombinant FTF enzyme produced large amounts of fructo-oligosaccharides (FOS) with beta-(2-->1)-linked fructosyl units, plus a high-molecular-weight fructan polymer (>10(7)) with beta-(2-->1) linkages (an inulin). FOS, but not inulin, was found in supernatants of L. reuteri strain 121 cultures grown on medium containing sucrose. Bacterial inulin production has been reported for only Streptococcus mutans strains. FOS production has been reported for a few bacterial strains. This paper reports the first-time isolation and molecular characterization of (i) a Lactobacillus ftf gene, (ii) an inulosucrase associated with a generally regarded as safe bacterium, (iii) an FTF enzyme synthesizing both a high molecular weight inulin and FOS, and (iv) an FTF protein containing a cell wall-anchoring LPXTG motif. The biological relevance and potential health benefits of an inulosucrase associated with an L. reuteri strain remain to be established.
Project description:CONTEXT:Given the obesity epidemic, effective but resource-efficient weight loss treatments are needed. Stepped-treatment approaches customize interventions based on milestone completion and can be more effective while costing less to administer than conventional treatment approaches. OBJECTIVE:To determine whether a stepped-care weight loss intervention (STEP) compared with a standard behavioral weight loss intervention (SBWI) would result in greater weight loss. DESIGN, SETTING, AND PARTICIPANTS:A randomized clinical trial of 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33% nonwhite, and 83% female) who were randomized to SBWI (n = 165) or STEP (n = 198) at 2 universities affiliated with academic medical centers in the United States (Step-Up Study). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. INTERVENTIONS:All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals. MAIN OUTCOME MEASURE:Mean change in weight over 18 months. Additional outcomes included resting heart rate and blood pressure, waist circumference, body composition, fitness, physical activity, dietary intake, and cost of the program. RESULTS:Of the 363 participants randomized, 260 (71.6%) provided a measure of mean change in weight over 18 months. The 18-month intervention resulted in weight decreasing from 93.1 kg (95% CI, 91.0 to 95.2 kg) to 85.6 kg (95% CI, 83.4 to 87.7 kg) (P < .001) in the SBWI group and from 92.7 kg (95% CI, 90.8 to 94.6 kg) to 86.4 kg (95% CI, 84.5 to 88.4 kg) in the STEP group (P < .001). The percentage change in weight from baseline to 18 months was -8.1% (95% CI, -9.4% to -6.9%) in the SBWI group (P < .001) compared with -6.9% (95% CI, -8.0% to -5.8%) in the STEP group (P < .001). Although the between-group difference in 18-month weight loss was not statistically different (-1.3 kg [95% CI, -2.8 to 0.2 kg]; P = .09), there was a significant group × time interaction effect (P = .03). The cost per participant was $1357 (95% CI, $1272 to $1442) for the SBWI group vs $785 (95% CI, $739 to $830) for the STEP group (P < .001). Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness. CONCLUSIONS:Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. Compared with SBWI, STEP resulted in clinically meaningful weight loss that cost less to implement. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00714168.
Project description:Family members of consumers with mental illness often play important roles in initiating and supporting treatment. Self-help programs such as the National Alliance on Mental Illness (NAMI) Family-to-Family Education Program (FTF) have been shown to provide a variety of benefits for family members. Despite recognizing the benefits of FTF, little is known about who may benefit most, and in what ways they might benefit. One group of interest is family members of younger consumers, a group shown to report more negative caregiving experiences and more depression and anxiety than caregivers of older consumers. The current study assesses whether relatives of youth (ages 8-18) differ in their response to FTF as opposed to relatives of adults (19 years and older). Results suggest that all members benefit from FTF. Family members of youth in FTF, however, reported gains more pronounced on their depressive symptoms, and negative perceptions and experiences, relative to family members of adults. The importance of peer support programs is discussed, as well as the specific usefulness of these programs to effectively address concerns of relatives of youth with serious mental health concerns.
Project description:Advances in genomics have transformed our ability to identify the genetic causes of rare diseases (RDs), yet we have a limited understanding of the mechanistic roles of most genes in health and disease. When a novel RD gene is first discovered, there is minimal insight into its biological function, the pathogenic mechanisms of disease-causing variants, and how therapy might be approached. To address this gap, the Canadian Rare Diseases Models and Mechanisms (RDMM) Network was established to connect clinicians discovering new disease genes with Canadian scientists able to study equivalent genes and pathways in model organisms (MOs). The Network is built around a registry of more than 500 Canadian MO scientists, representing expertise for over 7,500 human genes. RDMM uses a committee process to identify and evaluate clinician-MO scientist collaborations and approve 25,000 Canadian dollars in catalyst funding. To date, we have made 85 clinician-MO scientist connections and funded 105 projects. These collaborations help confirm variant pathogenicity and unravel the molecular mechanisms of RD, and also test novel therapies and lead to long-term collaborations. To expand the impact and reach of this model, we made the RDMM Registry open-source, portable, and customizable, and we freely share our committee structures and processes. We are currently working with emerging networks in Europe, Australia, and Japan to link international RDMM networks and registries and enable matches across borders. We will continue to create meaningful collaborations, generate knowledge, and advance RD research locally and globally for the benefit of patients and families living with RD.
Project description:Dietary treatment is important in management of type 2 diabetes or prediabetes, but uncertainty exists about the optimal diet. We randomized adults (n?=?34) with glycated hemoglobin (HbA1c)?>?6.0% and elevated body weight (BMI?>?25) to a very low-carbohydrate ketogenic (LCK) diet (n?=?16) or a moderate-carbohydrate, calorie-restricted, low-fat (MCCR) diet (n?=?18). All participants were encouraged to be physically active, get sufficient sleep, and practice behavioral adherence strategies based on positive affect and mindful eating. At 12 months, participants in the LCK group had greater reductions in HbA1c levels (estimated marginal mean (EMM) at baseline?=?6.6%, at 12 mos?=?6.1%) than participants in MCCR group (EMM at baseline?=?6.9%, at 12 mos?=?6.7%), p?=?.007. Participants in the LCK group lost more weight (EMM at baseline?=?99.9?kg, at 12 mos?=?92.0?kg) than participants in the MCCR group (EMM at baseline?=?97.5?kg, at 12 mos?=?95.8?kg), p?<?.001. The LCK participants experienced larger reductions in diabetes-related medication use; of participants who took sulfonylureas or dipeptidyl peptidase-4 inhibitors at baseline, 6/10 in the LCK group discontinued these medications compared with 0/6 in the MCCR group (p?=?.005). In a 12-month trial, adults with elevated HbA1c and body weight assigned to an LCK diet had greater reductions in HbA1c, lost more weight, and reduced more medications than those instructed to follow an MCCR diet.