Randomized clinical trials of weight loss: Pragmatic and digital strategies and innovations

Jain, Bhav; Bajaj, Simar S.; Stanford, Fatima Cody

doi:10.1016/j.cct.2022.106687

Cited by 3 publications

(1 citation statement)

References 14 publications

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“…Video meetings might also alleviate barriers to participation related to childcare, as women could participate in groups while their children sleep, engage in other activities at their home, or participate during lunch or another break during their workday. Another option may be a hybrid approach [81], such as an intervention delivered primarily remotely with a few in-person meetings, an approach that has been shown to be effective in low-income postpartum women [82]. Future research could explore the acceptability and efficacy of delivering a postpartum weight loss intervention via synchronous video group meetings, either in place of in-person meetings or in addition to an intervention delivered primarily digitally.…”

Section: Principal Findingsmentioning

confidence: 99%

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial

Waring¹,

Pagoto²,

Simas³

et al. 2023

JMIR Mhealth Uhealth

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Background Postpartum weight retention contributes to weight gain and obesity. Remotely delivered lifestyle interventions may be able to overcome barriers to attending in-person programs during this life phase. Objective This study aimed to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups. Feasibility outcomes were recruitment, sustained participation, contamination, retention, and feasibility of study procedures. Percent weight loss at 6 and 12 months were exploratory outcomes. Methods Women with overweight or obesity who were 8 weeks to 12 months post partum were randomized to receive a 6-month behavioral weight loss intervention based on the Diabetes Prevention Program lifestyle intervention via Facebook or in-person groups. Participants completed assessments at baseline, 6 months, and 12 months. Sustained participation was defined by intervention meeting attendance or visible engagement in the Facebook group. We calculated percent weight change for participants who provided weight at each follow-up. Results Among individuals not interested in the study, 68.6% (72/105) were not interested in or could not attend in-person meetings and 2.9% (3/105) were not interested in the Facebook condition. Among individuals excluded at screening, 18.5% (36/195) were ineligible owing to reasons related to the in-person condition, 12.3% (24/195) related to the Facebook condition, and 2.6% (5/195) were unwilling to be randomized. Randomized participants (n=62) were a median of 6.1 (IQR 3.1-8.3) months post partum, with a median BMI of 31.7 (IQR 28.2-37.4) kg/m2. Retention was 92% (57/62) at 6 months and 94% (58/62) at 12 months. The majority (21/30, 70%) of Facebook and 31% (10/32) of in-person participants participated in the last intervention module. Half (13/26, 50%) of Facebook and 58% (15/26) of in-person participants would be likely or very likely to participate again if they had another baby, and 54% (14/26) and 70% (19/27), respectively, would be likely or very likely to recommend the program to a friend. In total, 96% (25/26) of Facebook participants reported that it was convenient or very convenient to log into the Facebook group daily compared with 7% (2/27) of in-person participants who said it was convenient or very convenient to attend group meetings each week. Average weight loss was 3.0% (SD 7.2%) in the Facebook condition and 5.4% (SD 6.8%) in the in-person condition at 6 months, and 2.8% (SD 7.4%) in the Facebook condition and 4.8% (SD 7.6%) in the in-person condition at 12 months. Conclusions Barriers to attending in-person meetings hampered recruitment efforts and intervention participation. Although women found the Facebook group convenient and stayed engaged in the group, weight loss appeared lower. Research is needed to further develop care models for postpartum weight loss that balance accessibility with efficacy. Trial Registration ClinicalTrials.gov, NCT03700736; https://clinicaltrials.gov/ct2/show/NCT03700736

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Section: Principal Findingsmentioning

confidence: 99%

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial

Waring¹,

Pagoto²,

Simas³

et al. 2023

JMIR Mhealth Uhealth

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Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Hohenschurz-Schmidt,

Cherkin,

Rice

et al. 2024

Pain

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Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

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Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial (Preprint)

Waring¹,

Pagoto²,

Simas³

et al. 2022

Preprint

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BACKGROUND Postpartum weight retention contributes to weight gain and obesity. Remotely delivered lifestyle interventions may be able to overcome barriers to attending in-person programs during this life phase. OBJECTIVE This study aimed to conduct a randomized feasibility pilot trial of a 6-month postpartum weight loss intervention delivered via Facebook or in-person groups. Feasibility outcomes were recruitment, sustained participation, contamination, retention, and feasibility of study procedures. Percent weight loss at 6 and 12 months were exploratory outcomes. METHODS Women with overweight or obesity who were 8 weeks to 12 months post partum were randomized to receive a 6-month behavioral weight loss intervention based on the Diabetes Prevention Program lifestyle intervention via Facebook or in-person groups. Participants completed assessments at baseline, 6 months, and 12 months. Sustained participation was defined by intervention meeting attendance or visible engagement in the Facebook group. We calculated percent weight change for participants who provided weight at each follow-up. RESULTS Among individuals not interested in the study, 68.6% (72/105) were not interested in or could not attend in-person meetings and 2.9% (3/105) were not interested in the Facebook condition. Among individuals excluded at screening, 18.5% (36/195) were ineligible owing to reasons related to the in-person condition, 12.3% (24/195) related to the Facebook condition, and 2.6% (5/195) were unwilling to be randomized. Randomized participants (n=62) were a median of 6.1 (IQR 3.1-8.3) months post partum, with a median BMI of 31.7 (IQR 28.2-37.4) kg/m<sup>2</sup>. Retention was 92% (57/62) at 6 months and 94% (58/62) at 12 months. The majority (21/30, 70%) of Facebook and 31% (10/32) of in-person participants participated in the last intervention module. Half (13/26, 50%) of Facebook and 58% (15/26) of in-person participants would be likely or very likely to participate again if they had another baby, and 54% (14/26) and 70% (19/27), respectively, would be likely or very likely to recommend the program to a friend. In total, 96% (25/26) of Facebook participants reported that it was convenient or very convenient to log into the Facebook group daily compared with 7% (2/27) of in-person participants who said it was convenient or very convenient to attend group meetings each week. Average weight loss was 3.0% (SD 7.2%) in the Facebook condition and 5.4% (SD 6.8%) in the in-person condition at 6 months, and 2.8% (SD 7.4%) in the Facebook condition and 4.8% (SD 7.6%) in the in-person condition at 12 months. CONCLUSIONS Barriers to attending in-person meetings hampered recruitment efforts and intervention participation. Although women found the Facebook group convenient and stayed engaged in the group, weight loss appeared lower. Research is needed to further develop care models for postpartum weight loss that balance accessibility with efficacy. CLINICALTRIAL ClinicalTrials.gov, NCT03700736; https://clinicaltrials.gov/ct2/show/NCT03700736

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Randomized clinical trials of weight loss: Pragmatic and digital strategies and innovations

Cited by 3 publications

References 14 publications

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial

Methods for pragmatic randomized clinical trials of pain therapies: IMMPACT statement

Delivering a Postpartum Weight Loss Intervention via Facebook or In-Person Groups: Results From a Randomized Pilot Feasibility Trial (Preprint)

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