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Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

ABSTRACT: Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months.Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression.Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.

SUBMITTER: Foley P

PROVIDER: S-EPMC4885789 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

Foley Perry P Steinberg Dori D Levine Erica E Askew Sandy S Batch Bryan C BC Puleo Elaine M EM Svetkey Laura P LP Bosworth Hayden B HB DeVries Abigail A Miranda Heather H Bennett Gary G GG

Contemporary clinical trials 20160317

<h4>Introduction</h4>Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.<h4>Methods</h4>Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to u ...[more]

PMID: 26995281

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Project description:BackgroundFor patients with obesity who are not ready for or experience barriers to weight loss, clinical practice guidelines recommend provider counseling on preventing further weight gain as a first-line treatment approach. Unfortunately, evidence-based weight gain prevention interventions are not routinely available within primary care. To address this gap, we will implement a pragmatic 12-month randomized controlled trial of a digital weight gain prevention intervention delivered to patients receiving primary care within a network of Federally Qualified Community Health Centers in central North Carolina.MethodsBalance (Equilibrio in Spanish) is a pragmatic effectiveness trial that will randomize adult patients who have overweight or obesity (BMI of 25-40 kg/m2) to either: 1) a weight gain prevention intervention with tailored behavior change goals and tracking, daily weighing on a network-connected electronic scale, and responsive weight and goal coaching delivered remotely by health center registered dietitians; or 2) a usual care program with automated healthy living text messages and print materials and routine primary care. The primary outcome will be weight gain prevention at 24-months, defined as ≤3% change in baseline weight. To align with its pragmatic design, trial outcome data will be pulled from the electronic health record of the community health center network.DiscussionFor underserved, often rurally-located patients with obesity, digital approaches to promote a healthy lifestyle can curb further weight gain. Yet enrolling medically vulnerable patients into a weight gain prevention trial, many of whom are from racial/ethnic minorities, can be difficult. Despite these potential challenges, we plan to recruit a large, diverse sample from rural areas, and will implement a remotely-delivered weight gain prevention intervention to medically vulnerable patients. Upcoming trial results will demonstrate the effectiveness of this pragmatic approach to implement and evaluate a digital weight gain prevention intervention within primary care.Trials registrationNCT03003403 . Registered December 28, 2016.

Project description:BACKGROUND:Obesity treatment focuses primarily on reducing overall caloric intake with limited focus on improving diet quality. The Dietary Approaches to Stop Hypertension (DASH) dietary pattern is effective in managing hypertension and other chronic conditions, yet it is not clear whether behavioral weight control interventions improve DASH adherence. We conducted a post hoc analysis of a behavioral weight loss intervention that did not emphasize diet quality and examined whether the intervention impacted DASH adherence in medically vulnerable community health center patients. METHODS:Participants (n=306) were enrolled in Track, a randomized controlled weight loss intervention for patients with elevated cardiovascular risk. The trial compared usual care to an intervention with weekly self-monitoring, tailored feedback on diet and exercise goals, and dietitian and provider counseling in community health centers. Dietary intake was measured using the Block Food Frequency Questionnaires collected at baseline and 12 months. DASH adherence was determined using previously validated scoring indices that assessed adherence based on recommended nutrient or food group targets. Total scores for both indices ranged from 0 to 9, with higher scores indicating greater DASH adherence. RESULTS:The mean (and standard deviation [SD]) age of participants was 51.1 (SD=8.8) years and the mean body mass index was 35.9 (SD=3.9). Most were female (69%) and black (51%); 13% were Hispanic. Half (51%) had an annual income <$25,000 and 33% had both diabetes and hypertension. At baseline, the mean DASH nutrient score was 1.81 (SD=1.42) with 6% achieving at least a score of 4.5. Similar scores were seen for the DASH foods index. The intervention group saw significantly greater, albeit small, improvements in mean DASH nutrient score (intervention: 1.28 [SD=1.5] vs control: 0.20 [SD=1.3]; P<0.001), and there was no difference in DASH food score between study arms. There were no significant predictors of change in DASH score and no association between DASH adherence and changes in blood pressure. Within the intervention arm, improvements in DASH nutrient score were associated with greater weight loss (r=-0.28; P=0.003). CONCLUSION:Although the intervention was not designed to increase adoption of DASH, the Track intervention produced significant weight loss and small improvements in DASH adherence. Despite these small improvements, overall adoption of DASH was poor among the medically vulnerable patients enrolled in Track. To further reduce chronic disease burden, weight loss interventions should include a focus on both caloric restriction and increasing diet quality.

Project description:BackgroundGoals for Eating and Moving (GEM) is a technology-assisted health coaching intervention to improve weight management in primary care at the Veterans Health Administration (VHA) that we designed through prior rigorous formative studies. GEM is integrated within the patient-centered medical home and utilizes student health coach volunteers to counsel patients and encourage participation in VHA's intensive weight management program, MOVE!. The primary aim of this study was to determine the feasibility and acceptability of GEM when compared to Enhanced Usual Care (EUC). Our secondary aim was to test the impact of GEM on weight, diet and physical activity when compared to EUC.MethodsVeterans with a Body Mass Index ≥30 kg/m2 or 25-29.9 kg/m2 with comorbidities (n = 45) were recruited in two phases and randomized to GEM (n = 22) or EUC (n = 23). We collected process measures (e.g. number of coaching calls completed, number and types of lifestyle goals, counseling documentation) and qualitative feedback on quality of counseling and acceptability of call duration. We also measured weight and behavioral outcomes.ResultsGEM participants reported receiving high quality counseling from health coaches and that call duration and frequency were acceptable. They received 5.9 (SD = 3.7) of 12 coaching calls on average, and number of coaching calls completed was associated with greater weight loss at 6-months in GEM participants (Spearman Coefficient = 0.71, p < 0.001). Four participants from GEM and two from EUC attended the MOVE! program. PCPs completed clinical reminders in 12% of PCP visits with GEM participants. Trends show that GEM participants (n = 21) tended to lose more weight at 3-, 6-, and 12-months as compared to EUC, but this was not statistically significant. There were no significant differences in diet or physical activity.ConclusionsWe found that a technology assisted health coaching intervention delivered within primary care using student health coaches was feasible and acceptable to Veteran patients. This pilot study helped elucidate challenges such as low provider engagement, difficulties with health coach continuity, and low patient attendance in MOVE! which we have addressed and plan to test in future studies.Trial registrationNCT03006328 Retrospectively registered on December 30, 2016.

Project description:Background:Screening for colorectal cancer (CRC) reduces mortality, yet more than one third of age-eligible Americans are unscreened. Objective:To examine the effect of a digital health intervention, Mobile Patient Technology for Health-CRC (mPATH-CRC), on rates of CRC screening. Design:Randomized clinical trial. (ClinicalTrials.gov: NCT02088333). Setting:6 community-based primary care practices. Participants:450 patients (223 in the mPATH-CRC group and 227 in usual care) scheduled for a primary care visit and due for routine CRC screening. Intervention:An iPad application that displays a CRC screening decision aid, lets patients order their own screening tests, and sends automated follow-up electronic messages to support patients. Measurements:The primary outcome was chart-verified completion of CRC screening within 24 weeks. Secondary outcomes were ability to state a screening preference, intention to receive screening, screening discussions, and orders for screening tests. All outcome assessors were blinded to randomization. Results:Baseline characteristics were similar between groups; 37% of participants had limited health literacy, and 53% had annual incomes less than $20 000. Screening was completed by 30% of mPATH-CRC participants and 15% of those receiving usual care (logistic regression odds ratio, 2.5 [95% CI, 1.6 to 4.0]). Compared with usual care, more mPATH-CRC participants could state a screening preference, planned to be screened within 6 months, discussed screening with their provider, and had a screening test ordered. Half of mPATH-CRC participants (53%; 118 of 223) "self-ordered" a test via the program. Limitation:Participants were English speakers in a single health care system. Conclusion:A digital health intervention that allows patients to self-order tests can increase CRC screening. Future research should identify methods for implementing similar interventions in clinical care. Primary Funding Source:National Cancer Institute.

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Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

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Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.

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