Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

BACKGROUND: Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. METHODS: Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. RESULTS: Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. CONCLUSIONS: These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. TRIAL REGISTRATION: ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

IDEAS (Integrate, Design, Assess, and Share): A Framework and Toolkit of Strategies for the Development of More Effective Digital Interventions to Change Health Behavior.

Developing effective digital interventions to change health behavior has been a challenging goal for academics and industry players alike. Guiding intervention design using the best combination of approaches available is necessary if effective technologies are to be developed. Behavioral theory, design thinking, user-centered design, rigorous evaluation, and dissemination each have widely acknowledged merits in their application to digital health interventions. This paper introduces IDEAS, a step-by-step process for integrating these approaches to guide the development and evaluation of more effective digital interventions. IDEAS is comprised of 10 phases (empathize, specify, ground, ideate, prototype, gather, build, pilot, evaluate, and share), grouped into 4 overarching stages: Integrate, Design, Assess, and Share (IDEAS). Each of these phases is described and a summary of theory-based behavioral strategies that may inform intervention design is provided. The IDEAS framework strives to provide sufficient detail without being overly prescriptive so that it may be useful and readily applied by both investigators and industry partners in the development of their own mHealth, eHealth, and other digital health behavior change interventions.

Iterative development of Vegethon: a theory-based mobile app intervention to increase vegetable consumption.

BACKGROUND: Mobile technology may serve as a cost-effective and scalable tool for delivering behavioral nutrition interventions. This research sought to iteratively develop a theory-driven mobile app, Vegethon, to increase vegetable consumption. METHODS: Development of Vegethon followed phases outlined by the IDEAS framework: 1) empathize with users (qualitative interviews, n = 18); 2) specify target behavior; 3) ground in behavioral theory; 4) ideate implementation strategies; 5) prototype potential products; 6) gather user feedback (qualitative interviews, n = 14; questionnaire, n = 41); 7) build minimum viable product; and 8) pilot potential efficacy and usability (pilot RCT, n = 17). Findings from each phase informed subsequent phases. The target population that informed intervention development was 18-50 years of age, had BMIs of 28-40 kg/m(2), and lived in the geographical area surrounding Stanford University. A full description of the final version of Vegethon is included in the paper. RESULTS: Qualitative findings that shaped initial intervention conception were: participants' interests in accountability without judgment; their desire for simple and efficient dietary self-monitoring; and the importance of planning meals in advance. Qualitative findings identified during intervention refinement were the need for a focus on vegetable self-monitoring; inclusion of vegetable challenges; simplification of features; advice and inspiration for eating vegetables; reminder notifications; and peer comparison. Pilot RCT findings suggested the initial efficacy, acceptance, and feasibility of the intervention. The final version of Vegethon enabled easy self-monitoring of vegetable consumption and included a range of features designed to engage the user (e.g., surprise challenges; leaderboard; weekly reports). Vegethon was coded for its inclusion of 18 behavior change techniques (BCTs) (e.g., goal setting; feedback; social comparison; prompts/cues; framing/reframing; identity). CONCLUSIONS: Vegethon is a theory-based, user-informed mobile intervention that was systematically developed using the IDEAS framework. Vegethon targets increased vegetable consumption among overweight adults and is currently being evaluated in a randomized controlled efficacy trial. TRIAL REGISTRATION: Clinical Trials.gov: NCT01826591.

Mobile Technology for Vegetable Consumption: A Randomized Controlled Pilot Study in Overweight Adults.

BACKGROUND: Mobile apps present a potentially cost-effective tool for delivering behavior change interventions at scale, but no known studies have tested the efficacy of apps as a tool to specifically increase vegetable consumption among overweight adults. OBJECTIVE: The purpose of this pilot study was to assess the initial efficacy and user acceptability of a theory-driven mobile app to increase vegetable consumption. METHODS: A total of 17 overweight adults aged 42.0 (SD 7.3) years with a body mass index (BMI) of 32.0 (SD 3.5) kg/m(2) were randomized to the use of Vegethon (a fully automated theory-driven mobile app enabling self-monitoring of vegetable consumption, goal setting, feedback, and social comparison) or a wait-listed control condition. All participants were recruited from an ongoing 12-month weight loss trial (parent trial). Researchers who performed data analysis were blinded to condition assignment. The primary outcome measure was daily vegetable consumption, assessed using an adapted version of the validated Harvard Food Frequency Questionnaire administered at baseline and 12 weeks after randomization. An analysis of covariance was used to assess differences in 12-week vegetable consumption between intervention and control conditions, controlling for baseline. App usability and satisfaction were measured via a 21-item post-intervention questionnaire. RESULTS: Using intention-to-treat analyses, all enrolled participants (intervention: 8; control: 9) were analyzed. Of the 8 participants randomized to the intervention, 5 downloaded the app and logged their vegetable consumption a mean of 0.7 (SD 0.9) times per day, 2 downloaded the app but did not use it, and 1 never downloaded it. Consumption of vegetables was significantly greater among the intervention versus control condition at the end of the 12-week pilot study (adjusted mean difference: 7.4 servings; 95% CI 1.4-13.5; P=.02). Among secondary outcomes defined a priori, there was significantly greater consumption of green leafy vegetables, cruciferous vegetables, and dark yellow vegetables (adjusted mean difference: 2.6, 1.6, and 0.8 servings; 95% CI 0.1-5.0, 0.1-3.2, and 0.3-1.4; P=.04, P=.04, and P=.004, respectively). Participants reported positive experiences with the app, including strong agreement with the statements "I have found Vegethon easy to use" and "I would recommend Vegethon to a friend" (mean 4.6 (SD 0.6) and 4.2 (SD 0.8), respectively, (on a 5-point scale). CONCLUSIONS: Vegethon demonstrated initial efficacy and user acceptability. A mobile app intervention may be useful for increasing vegetable consumption among overweight adults. The small sample size prevented precise estimates of effect sizes. Given the improved health outcomes associated with increases in vegetable consumption, these findings indicate the need for larger, longer-term evaluations of Vegethon and similar technologies among overweight adults and other suitable target groups. TRIAL REGISTRATION: ClinicalTrials.gov NCT01826591; https://clinicaltrials.gov/ct2/show/NCT01826591 (Archived by WebCite at http://www.webcitation.org/6hYDw2AOB).

Effect of raw milk on lactose intolerance: a randomized controlled pilot study.

PURPOSE: This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk. METHODS: We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen (H2) breath testing. Participants underwent 3, 8-day milk phases (raw vs 2 controls: pasteurized, soy) in randomized order separated by 1-week washout periods. On days 1 and 8 of each phase, milk consumption was 473 mL (16 oz); on days 2 to 7, milk dosage increased daily by 118 mL (4 oz), beginning with 118 mL (4 oz) on day 2 and reaching 710 mL (24 oz) on day 7. Outcomes were area under the breath H2 curve (AUC H2) and self-reported symptom severity (visual analog scales: flatulence/gas, audible bowel sounds, abdominal cramping, diarrhea). RESULTS: AUC H2 (mean ± standard error of the mean) was higher for raw vs pasteurized on day 1 (113 ± 21 vs 71 ± 12 ppm·min·10(-2), respectively, P = .01) but not day 8 (72 ± 14 vs 74 ± 15 ppm·min·10(-2), respectively, P = .9). Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage (P >.7). AUC H2 and symptom severities were higher for both dairy milks compared with soy milk. CONCLUSIONS: Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption. These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance.