Dataset Information

Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

ABSTRACT:

Objective

Behavioral weight management trials are traditionally conducted in-person. The COVID-19 shutdown halted in-person operations, forcing investigators to develop new methods for remote treatment and assessment delivery without additional funding for website development or remote equipment. This study examined the feasibility and acceptability of remote procedures from an ongoing weight management trial impacted by COVID-19.

Methods

Using a quasi-experimental longitudinal design, in-person (pre-COVID) and remote (COVID) treatment and assessment procedures were used. Attendance at in-person versus remote (videoconference) treatment sessions was compared. Acceptability of treatment modalities (in-person vs. remote) was examined via self-report. Validity and reliability were assessed on bathroom scales. Attendance at remote (videoconference + mailed, scales) versus in-person assessment sessions was compared. Finally, exploratory analyses were conducted to determine whether participant characteristics moderated the effects.

Results

Remote treatment attendance was significantly better than in-person. Overall, there was no significant difference in modality preference. However, Hispanic (vs. non-Hispanic) individuals had greater preference for remote options and attended more remote treatment sessions. Bathroom scales demonstrated excellent validity and reliability. Adherence to remote and in-person assessment sessions was similar.

Conclusions

COVID-19 has provided an opportunity to rethink how we conduct research. Results herein establish an evidence-base to support a paradigm shift to remote clinical trial procedures. Such a shift may enhance diversity in clinical trials.

SUBMITTER: Leahey TM

PROVIDER: S-EPMC9722444 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

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Publications

Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

Leahey Tricia M TM Pham Julie J Denmat Zeely Z Jenkins Kyrstyn K Harris-Starling Cheyenne C Gilder Carnisha C Gorin Amy A AA

Obesity science & practice 20220518 6

<h4>Objective</h4>Behavioral weight management trials are traditionally conducted in-person. The COVID-19 shutdown halted in-person operations, forcing investigators to develop new methods for remote treatment and assessment delivery without additional funding for website development or remote equipment. This study examined the feasibility and acceptability of remote procedures from an ongoing weight management trial impacted by COVID-19.<h4>Methods</h4>Using a quasi-experimental longitudinal de ...[more]

PMID: 36483120

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Project description:ImportanceOnline programs may help with weight loss but have not been widely implemented in routine primary care.ObjectiveTo compare the effectiveness of a combined intervention, including an online weight management program plus population health management, with the online program only and with usual care.Design, setting, and participantsCluster randomized trial with enrollment from July 19, 2016, through August 10, 2017, at 15 primary care practices in the US. Eligible participants had a scheduled primary care visit and were aged 20 to 70 years, had a body mass index between 27 and less than 40, and had a diagnosis of hypertension or type 2 diabetes. Follow-up ended on May 8, 2019.InterventionsParticipants in the usual care group (n = 326) were mailed general information about weight management. Participants in the online program only group (n = 216) and the combined intervention group (n = 298) were registered for the online program. The participants in the combined intervention group also received weight-related population health management, which included additional support from nonclinical staff who monitored their progress in the online program and conducted periodic outreach.Main outcomes and measuresThe primary outcome was weight change at 12 months based on measured weights recorded in the electronic health record. Weight change at 18 months was a secondary outcome.ResultsAmong the 840 participants who enrolled (mean age, 59.3 years [SD, 8.6 years]; 60% female; 76.8% White), 732 (87.1%) had a recorded weight at 12 months and the missing weights for the remaining participants were imputed. There was a significant difference in weight change at 12 months by group with a mean weight change of -1.2 kg (95% CI, -2.1 to -0.3 kg) in the usual care group, -1.9 kg (95% CI, -2.6 to -1.1 kg) in the online program only group, and -3.1 kg (95% CI, -3.7 to -2.5 kg) in the combined intervention group (P < .001). The difference in weight change between the combined intervention group and the usual care group was -1.9 kg (97.5% CI, -2.9 to -0.9 kg; P < .001) and the difference between the combined intervention group and the online program only group was -1.2 kg (95% CI, -2.2 to -0.3 kg; P = .01). At 18 months, the mean weight change was -1.9 kg (95% CI, -2.8 to -1.0 kg) in the usual care group, -1.1 kg (95% CI, -2.0 to -0.3 kg) in the online program only group, and -2.8 kg (95% CI, -3.5 to -2.0 kg) in the combined intervention group (P < .001).Conclusions and relevanceAmong primary care patients with overweight or obesity and hypertension or type 2 diabetes, combining population health management with an online program resulted in a small but statistically significant greater weight loss at 12 months compared with usual care or the online program only. Further research is needed to understand the generalizability, scalability, and durability of these findings.Trial registrationClinicalTrials.gov Identifier: NCT02656693.

Project description:BackgroundBehavioral weight loss interventions promote clinically significant weight loss over 12 months, but weight regain remains problematic and a substantial proportion of participants do not achieve long-term weight loss maintenance. Novel methods are needed that instill habit strength for sustaining weight control behaviors long term. Virtual reality (VR) has the potential to provide opportunities within behavioral treatment for patients to practice desired weight control behaviors in the frequency and magnitude necessary to build durable habits. A pilot randomized trial was done to test the feasibility integrating virtual reality (VR) into standard behavioral weight loss treatment.MethodsParticipants were 15 adults (43 years; 46.7% Hispanic), with overweight or obesity who were randomly assigned to a 4-week Standard Behavioral Weight Loss plus Non-Weight-Related VR app (i.e., Control Group) or Standard Behavioral Weight Loss plus Weight-Related VR app (i.e., Intervention Group). The Intervention's VR tool was designed to enable practice of behavioral skills taught in weekly group meetings, including managing social and home environmental cues for eating and activity.ResultsParticipants were recruited over 3 months, and retention at the final assessment visit was high (86.6%). The VR footage and resulting app were rated as highly realistic (6.7 on a 10-point scale), and the VR program overall was rated as highly satisfactory (3.6 on a 4-point scale). Adverse effects of eye strain and motion sickness were minimal (~ 2 on a 7-point scale). As expected, the intervention and control groups both lost weight and unadjusted means (SD) averaged 3.4% (2.7) and 2.3% (3.6), respectively, over the 4 weeks. Overall, participants reported preferring a VR approach above traditional weight loss programs (rating of 5 on a 7-point scale).ConclusionsFuture research is needed to develop and test the feasibility of using VR for other weight control skills with a larger sample size and longer evaluation period to determine if VR can improve standard behavioral weight loss outcomes by intensifying practice opportunities and building habit strength for weight loss maintenance.Trial registrationNCT04534088 ; date of registration: 09/01/2020, retrospectively registered.

Project description:BackgroundAlthough there is a rise in the use of mobile health (mHealth) tools to support chronic disease management, evidence derived from theory-driven design is lacking.ObjectiveThe objective of this study was to determine the impact of an mHealth app that incorporated theory-driven trigger messages. These messages took different forms following the Fogg behavior model (FBM) and targeted self-efficacy, knowledge, and self-care. We assess the feasibility of our app in modifying these behaviors in a pilot study involving individuals with diabetes.MethodsThe pilot randomized unblinded study comprised two cohorts recruited as employees from within a health care system. In total, 20 patients with type 2 diabetes were recruited for the study and a within-subjects design was utilized. Each participant interacted with an app called capABILITY. capABILITY and its affiliated trigger (text) messages integrate components from social cognitive theory (SCT), FBM, and persuasive technology into the interactive health communications framework. In this within-subjects design, participants interacted with the capABILITY app and received (or did not receive) text messages in alternative blocks. The capABILITY app alone was the control condition along with trigger messages including spark and facilitator messages. A repeated-measures analysis of variance (ANOVA) was used to compare adherence with behavioral measures and engagement with the mobile app across conditions. A paired sample t test was utilized on each health outcome to determine changes related to capABILITY intervention, as well as participants' classified usage of capABILITY.ResultsPre- and postintervention results indicated statistical significance on 3 of the 7 health survey measures (general diet: P=.03; exercise: P=.005; and blood glucose: P=.02). When only analyzing the high and midusers (n=14) of capABILITY, we found a statistically significant difference in both self-efficacy (P=.008) and exercise (P=.01). Although the ANOVA did not reveal any statistically significant differences across groups, there is a trend among spark conditions to respond more quickly (ie, shorter log-in lag) following the receipt of the message.ConclusionsOur theory-driven mHealth app appears to be a feasible means of improving self-efficacy and health-related behaviors. Although our sample size is too small to draw conclusions about the differential impact of specific forms of trigger messages, our findings suggest that spark triggers may have the ability to cue engagement in mobile tools. This was demonstrated with the increased use of capABILITY at the beginning and conclusion of the study depending on spark timing. Our results suggest that theory-driven personalization of mobile tools is a viable form of intervention.Trial registrationClinicalTrials.gov NCT04132089; http://clinicaltrials.gov/ct2/show/NCT004122089.

Project description:BackgroundExcessive gestational weight gain (GWG) is common and can result in maternal and child health complications. Pragmatic behavioral interventions that can be incorporated into standard obstetric care are needed, and financial incentives are a promising approach.ObjectiveThe aim of this study is to evaluate the feasibility of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, in a behavioral program. The program provided small incentives for meeting behavioral goals of self-weighing and physical activity as well as larger outcome incentives for meeting GWG goals.MethodsWe recruited 40 adult women in their first trimester of pregnancy from February 2019 to September 2019 at an obstetric clinic. Participants were randomized to 3 intervention components using a 2×2×2 factorial design: daily incentives for self-weighing (lottery vs certain loss), incentives for adhering to the Institute of Medicine's GWG guidelines based on BMI category (monthly vs overall), and incentives for reaching physical activity goals (yes vs no). Participants were asked to complete daily weigh-ins using the Withings Body wireless scale provided by the study, as well as wear a physical activity tracker (Fitbit Flex 2). Feasibility outcomes of recruitment, randomization, and retention, as well as treatment engagement and intervention satisfaction, were assessed. Weight assessments were conducted at baseline, 32-week gestation, and 36-week gestation.ResultsParticipants were enrolled at, on average, 9.6 (SD 1.8) weeks' gestation. Of the 39 participants who were oriented to their condition and received the intervention, 24 (62%) were Black or African American, 30 (77%) were not married, and 29 (74%) had an annual household income of less than US $50,000. Of the 39 participants, 35 (90%) completed the follow-up data collection visit. Participants were generally quite positive about the intervention components, with a particular emphasis on the helpfulness of, and the enjoyment of using, the e-scale in both the quantitative and qualitative feedback. Participants who received the loss incentive, on average, had 2.86 times as many days of self-weighing as those who received the lottery incentive. Participants had a relatively low level of activity, with no difference between those who received a physical activity incentive and those who did not.ConclusionsA financial incentive-based pragmatic intervention was feasible and acceptable for pregnant women for promoting self-weighing, physical activity, and healthy GWG. Participants were successfully recruited early in their first trimester of pregnancy and retained for follow-up data collection in the third trimester. Participants demonstrated promising engagement in self-weighing, particularly with loss-based incentives, and reported finding the self-weighing especially helpful. This study supports further investigation of pragmatic, clinic-based financial incentive-based interventions for healthy GWG behaviors.Trial registrationClinicalTrials.gov NCT03834194; https://clinicaltrials.gov/ct2/show/NCT03834194.

Project description:BackgroundAlthough calorie tracking is one of the strongest predictors of weight loss in behavioral weight loss interventions, low rates of adherence are common.ObjectiveThis study aims to examine the feasibility and acceptability of using the Slip Buddy app during a 12-week web-based weight loss program.MethodsWe conducted a randomized pilot trial to evaluate the feasibility and acceptability of using the Slip Buddy app compared with a popular commercial calorie tracking app during a counselor-led, web-based behavioral weight loss intervention. Adults who were overweight or obese were recruited on the web and randomized into a 12-week web-based weight loss intervention that included either the Slip Buddy app or a commercial calorie tracking app. Feasibility outcomes included retention, app use, usability, slips reported, and contextual factors reported at slips. Acceptability outcomes included ratings of how helpful, tedious, taxing, time consuming, and burdensome using the assigned app was. We described weight change from baseline to 12 weeks in both groups as an exploratory outcome. Participants using the Slip Buddy app provided feedback on how to improve it during the postintervention focus groups.ResultsA total of 75% (48/64) of the participants were female and, on average, 39.8 (SD 11.0) years old with a mean BMI of 34.2 (SD 4.9) kg/m2. Retention was high in both conditions, with 97% (31/32) retained in the Slip Buddy condition and 94% (30/32) retained in the calorie tracking condition. On average, participants used the Slip Buddy app on 53.8% (SD 31.3%) of days, which was not significantly different from those using the calorie tracking app (mean 57.5%, SD 28.4% of days), and participants who recorded slips (30/32, 94%) logged on average 17.9 (SD 14.4) slips in 12 weeks. The most common slips occurred during snack times (220/538, 40.9%). Slips most often occurred at home (297/538, 55.2%), while working (153/538, 28.4%), while socializing (130/538, 24.2%), or during screen time (123/538, 22.9%). The conditions did not differ in participants' ratings of how their assigned app was tedious, taxing, or time consuming (all values of P>.05), but the calorie tracking condition gave their app higher helpfulness and usability ratings (all values of P<.05). Technical issues were the most common type of negative feedback, whereas simplicity was the most common type of positive feedback. Weight losses of ≥5% of baseline weight were achieved by 31% (10/32) of Slip Buddy participants and 34% (11/32) of calorie tracking participants.ConclusionsSelf-monitoring of dietary lapses and the contextual factors associated with them may be an alternative for people who do not prefer calorie tracking. Future research should examine patient characteristics associated with adherence to different forms of dietary self-monitoring.Trial registrationClinicalTrials.gov NCT02615171; https://clinicaltrials.gov/ct2/show/NCT02615171.

Dataset Information

Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

Objective

Methods

Results

Conclusions

Publications

Feasibility of online behavioral clinical trials: The future of weight management randomized clinical trials?

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