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The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

ABSTRACT: Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and SM + FB + attending three in-person group sessions (Group 3). The sample (N = 39) was mostly white and female with a mean body mass index of 33.76 kg/m2. Adherence to dietary SM was recorded daily, weight was assessed at baseline and 12 weeks. The mean percentage of days adherent to dietary SM was similar among Groups 1, 2, and 3 (p = 0.66) at 53.50% vs. 55.86% vs. 65.33%, respectively. At 12 weeks, all groups had a significant percent weight loss (p < 0.05), with no differences among groups (- 2.85% vs. - 3.14% vs. - 3.37%) (p = 0.95); 26% of the participants lost ? 5% of their baseline weight. Mean retention was 74% with no differences among groups (p = 0.37). All groups adhered to SM at levels comparable to or better than other weight loss studies and lost acceptable amounts of weight, with minimal intervention contact over 12 weeks. These preliminary findings suggest this 3-group approach testing SM alone vs. SM with real-time FB messages alone or supplemented with limited in-person group sessions warrants further testing in a larger, more diverse sample and for a longer intervention period.

SUBMITTER: Burke LE

PROVIDER: S-EPMC5388931 | biostudies-literature | 2017 Jun

REPOSITORIES: biostudies-literature

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The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

Burke Lora E LE Zheng Yaguang Y Ma Qianheng Q Mancino Juliet J Loar India I Music Edvin E Styn Mindi M Ewing Linda L French Brian B Sieworek Dan D Smailagic Asim A Sereika Susan M SM

Preventive medicine reports 20170331

Self-monitoring (SM) of food intake is central to weight loss treatment. Technology makes it possible to reinforce this behavior change strategy by providing real-time feedback (FB) tailored to the diary entry. To test the feasibility of providing 1-4 daily FB messages tailored to dietary recordings via a smartphone, we conducted a 12-week pilot randomized clinical trial in Pittsburgh, PA in US in 2015. We compared 3 groups: SM using the Lose It! smartphone app (Group 1); SM + FB (Group 2); and ...[more]

PMID: 28409090

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Project description:BackgroundPre-exposure prophylaxis (PrEP) is safe and effective in postpartum women. Human immunodeficiency virus self-testing (HIVST) for male partners combined with biofeedback counseling through real-time adherence measures may improve PrEP use among postpartum women.MethodsBetween August 2020 and April 2021, we randomized postpartum women who initiated PrEP in pregnancy 1:1 to the intervention group (HIVST + biofeedback counseling after urine tenofovir test) or to standard of care ([SOC] facility-based human immunodeficiency virus [HIV] tests and routine counseling without biofeedback). The outcomes of interest were PrEP adherence in the past 48-72 hours via urine tenofovir tests and partner HIV testing, measured 1-month after randomization. Secondary outcomes included the proportion of partners who tested for HIV and the discrepancy between self-reported PrEP adherence and urine tenofovir result.ResultsWe enrolled 106 women (median age = 26 years). At enrollment, 72% of women reported missing <2 doses in the past 7 days; 36% of women had tenofovir present in her urine. One month after enrollment, 62% (n = 33) of women in the intervention arm had tenofovir present in their urine compared to 34% (n = 18) in SOC (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.19-2.82; P = .001). Two thirds of women in the intervention arm reported that her partner tested for HIV (66%; n = 35), compared to 17% (n = 9) in SOC (RR = 3.89; 95% CI = 2.08-7.27; P < .001). Self-reported PrEP adherence (took PrEP >5 of last week) with no tenofovir in urine test was lower in the intervention group (17% vs 46%; RR = 0.33; 95% CI = 0.17-0.67; P = .03). No social or clinical adverse events were reported in the intervention arm.ConclusionsThe HIVST for partners and biofeedback counseling increased levels of recent PrEP adherence, pointing to the importance of these interventions to support PrEP use in this population.

Project description:BACKGROUND:The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. OBJECTIVE:The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. METHODS:The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ?18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. RESULTS:This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. CONCLUSIONS:A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. TRIAL REGISTRATION:ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):PRR1-10.2196/15029.

Project description:BackgroundSelf-monitoring (SM) is the centerpiece of behavioral weight loss treatment, but the efficacy of smartphone-delivered SM feedback (FB) has not been tested in large, long-term, randomized trials.ObjectiveThe aim of this study was to establish the efficacy of providing remote FB to diet, physical activity (PA), and weight SM on improving weight loss outcomes when comparing the SM plus FB (SM+FB) condition to the SM-only condition in a 12-month randomized controlled trial. The study was a single-site, population-based trial that took place in southwestern Pennsylvania, USA, conducted between 2018 and 2021. Participants were smartphone users age ≥18 years, able to engage in moderate PA, with a mean BMI between 27 and 43 kg/m2.MethodsAll participants received a 90-minute, one-to-one, in-person behavioral weight loss counseling session addressing behavioral strategies, establishing participants' dietary and PA goals, and instructing on use of the PA tracker (Fitbit Charge 2), smart scale, and diet SM app. Only SM+FB participants had access to an investigator-developed smartphone app that read SM data, in which an algorithm selected tailored messages sent to the smartphone up to 3 times daily. The SM-only participants did not receive any tailored FB based on SM data. The primary outcome was percent weight change from baseline to 12 months. Secondary outcomes included engagement with digital tools (eg, monthly percentage of FB messages opened and monthly percentage of days adherent to the calorie goal).ResultsParticipants (N=502) were on average 45.0 (SD 14.4) years old with a mean BMI of 33.7 (SD 4.0) kg/m2. The sample was 79.5% female (n=399/502) and 82.5% White (n=414/502). At 12 months, retention was 78.5% (n=394/502) and similar by group (SM+FB: 202/251, 80.5%; SM: 192/251, 76.5%; P=.28). There was significant percent weight loss from baseline in both groups (SM+FB: -2.12%, 95% CI -3.04% to -1.21%, P<.001; SM: -2.39%, 95% CI -3.32% to -1.47%; P<.001), but no difference between the groups (-0.27%; 95% CI -1.57% to 1.03%; t =-0.41; P=.68). Similarly, 26.3% (66/251) of the SM+FB group and 29.1% (73/251) of the SM group achieved ≥5% weight loss (chi-square value=0.49; P=.49). A 1% increase in FB messages opened was associated with a 0.10 greater percent weight loss at 12 months (b=-0.10; 95% CI -0.13 to -0.07; t =-5.90; P<.001). A 1% increase in FB messages opened was associated with 0.12 greater percentage of days adherent to the calorie goal per month (b=0.12; 95% CI 0.07-0.17; F=22.19; P<.001).ConclusionsThere were no significant between-group differences in weight loss; however, the findings suggested that the use of commercially available digital SM tools with or without FB resulted in a clinically significant weight loss in over 25% of participants. Future studies need to test additional strategies that will promote greater engagement with digital tools.Trial registrationClinicaltrials.gov NCT03367936; https://clinicaltrials.gov/ct2/show/NCT03367936.

Project description:Financial incentives could be used to improve adherence to behavioral weight loss interventions, increasing their effectiveness. This Phase IIb randomized pilot study evaluated the feasibility and acceptability of a study protocol for providing financial incentives for dietary self-monitoring and/or weight loss. Community-dwelling adults with obesity were enrolled in a 24 week, group-based weight loss program. Participants were randomized in a 2 × 2 factorial design to receive financial incentives for both dietary self-monitoring and weekly weight loss, just one, or neither. Participants could earn up to $300, evolving from fixed weekly payments to intermittent, variable payments. The notice of reward was provided by text message. The study was conducted in three successive cohorts to evaluate study procedure changes, including dietary approach, recruitment and retention strategies, text messaging, and incentives. Descriptive statistics calculated separately for each cohort described study performance relative to predefined targets for recruitment, including minority representation; retention; adherence; and weight loss. Acceptability was assessed via postintervention qualitative interviews. In Cohort 1 (n = 34), a low-carbohydrate diet was used. Recruitment, retention, adherence, and weight loss were adequate, but minority representation was not. For Cohort 2 (n = 31), employing an additional recruitment method and switching to a reduced-calorie diet yielded adequate recruitment, minority representation, retention, and adherence but less weight loss. Returning to a low-carbohydrate diet in Cohort 3 (n = 28) yielded recruitment, minority representation, retention, adherence, and weight loss similar to Cohort 2. Participant feedback informed changes to text message timing and content and incentive amount. Through successive cohorts, we optimized recruitment and retention strategies and text messaging. An adequately powered trial is warranted to evaluate the efficacy of these incentive structures for reducing weight. The trial registration number is NCT02691260.

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The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

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The SMARTER pilot study: Testing feasibility of real-time feedback for dietary self-monitoring.

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