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临床试验/NCT05241353
NCT05241353已完成不适用

A Randomized Pilot Trial of a Tailored, Reduced-Frequency Approach to Dietary Self-Monitoring for Weight Loss

Drexel University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2022年4月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Change in Baseline Percent Weight Loss at Week 12

研究概览

简要总结

This randomized pilot trial will compare two approaches to dietary self-monitoring for weight loss in the context of a low-intensity, remotely-delivered lifestyle modification program. Participants (N=40) will be randomized to perform detailed self-monitoring of all food and drink consumed each day or a reduced frequency, partial prescription involving recording only a subset of daily intake. The investigators will compare differences in weight loss as well as on relevant mechanistic, behavioral outcomes between groups at 12 weeks.

详细描述

Most lifestyle modification programs for weight loss require comprehensive, precise dietary self-monitoring (DSM) of all food and drink consumed each day. Although theoretically, such approaches should maximize the ability to identify dietary modifications leading to weight loss, the high level of burden associated with these requirements may produce suboptimal weight loss outcomes for many individuals by compromising DSM compliance, accuracy, and utilization for behavior change. A few prior trials have attempted to address this concern by relaxing the standard DSM requirement to record caloric intake precisely. However, such approaches are likely limited in efficacy because they reduce the utility DSM for implementing specific dietary changes. An alternative, as-of-yet untested approach to lower DSM burden would be to require that DSM be performed precisely but with reduced frequency, i.e., only during eating occasions strongly associated with eating patterns that threaten weight control. Thus, the purpose of the current pilot trial will be to compare the standard DSM protocol to a novel, reduced-frequency DSM approach in the context of a 12-week, low-intensity weight loss intervention. Participants (N = 40) will be randomized to receive either standard DSM advice or a reduced-frequency prescription and will receive four remotely-delivered individual coaching calls. The primary aim will be to investigate whether relative to standard DSM, reduced-frequency DSM can yield superior outcomes on four prospective indicators of long-term weight loss success (attitudes, DSM accuracy, utilization of DSM, and sustained compliance with DSM) and also produce comparable weight outcomes by 12 weeks.

All participants will receive a 12-week, low-intensity coaching-based intervention consisting of four individual coaching contacts. All study contacts will occur remotely using the HIPAA-compliant Zoom service at Drexel University. Participants will first complete preliminary eligibility screening via telephone and eligibility will be confirmed during an individual baseline assessment, during which participants will also receive an overview of study procedures. Following the baseline assessment but prior to the first coaching call, participants will engage in fully comprehensive, standard DSM for one week to generate data on the participant's typical dietary patterns, and these data will be used to tailor the DSM prescription in the reduced-frequency DSM group. Participants will also be provided with weekly electronic reading material on principles of behavioral weight control. The first coaching call will be one hour in duration and will provide an overview of general behavioral principles of weight control, including requiring the participant to set specific calorie reduction, self-monitoring and physical activity goals. Participants will also be randomized at during the first coaching call one-to-one fashion to either receive standard DSM advice or to receive a reduced frequency prescription that requires recording only a subset of eating each day throughout the intervention. Permuted block randomization will be performed, stratified on baseline BMI (groups: BMI <30, BMI 30-35, BMI >35). Depending on the participant's assignment, he/she/they will be assigned during the baseline coaching call to either continue recording all dietary intake each day (using the Fitbit mobile application) or record a subset of eating tailored to the individual's within-day dietary patterns using a simple algorithm. Subsequent coaching calls will focus on a review of adherence to dietary and physical activity goals and problem-solving solutions to the participant's stated barriers to adherence. Participants in the reduced-frequency group will also have opportunities to modify the self-monitoring prescription during subsequent coaching calls depending on the perceived feasibility of their current prescription. Lastly, participants in both groups will complete a post-treatment assessment during which self-report measures will be completed and skills to maintain after treatment will be reviewed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Randomization will be concealed from outcome assessors. The allocation sequence will also be blinded in advance from individuals involved in the randomization process. However, it will not be fully possible to blind participants due to the nature of the trial (i.e., assignments will be evident to participants).

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 years old
  • Currently living in the United States
  • Current body mass index (BMI) of 25-50 kg/m2, with individuals with BMI > 50 excluded due to the higher risk of medical complications
  • Access to a regular internet connection
  • Ability to understand and provide informed consent
  • Individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss
  • Proficiency in speaking, reading, and writing English
  • Ability to engage in physical activity, defined as the ability to walk at least the length of two city blocks without stopping
  • Access to or willing to purchase a digital wireless body weight scale

排除标准

  • Present involvement in another lifestyle modification or obesity treatment program
  • Currently breastfeeding, pregnant or planning to become pregnant within 4 months from the time of screening
  • Having lost more than 5% of body weight in the past 3 months
  • History of bariatric surgery
  • Acute suicide risk (exclude if present in the past 2 weeks or if any attempts were made in past 2 years)
  • Self-reported diagnosis of a medical or psychiatric condition that could make standard behavioral weight loss treatment contraindicated, including: insulin-dependent diabetes (type 1 or type 2; individuals with diabetes who do not take insulin will not be excluded), cancer, loss-of-control eating (three or more times in the past month), inappropriate compensatory behaviors to control weight (vomiting, misuse of laxatives or diuretics, or compelled exercise) in the past month, current unmedicated bipolar or psychotic disorder, or current psychiatric symptoms that would interfere with an individual's ability to complete the program.
  • Technological or interpersonal difficulties contraindicating participation in a remotely delivered coaching program

结局指标

主要结局

Change in Baseline Percent Weight Loss at Week 12

时间窗: Week 0 (Baseline), Week 12 (Post-Treatment)

Weight will be assessed at baseline and weekly throughout the intervention. Participants will be instructed to self-weigh on one consistent morning per week before 11am, following specific instructions (i.e., wear light clothing, keep scale on a flat surface, weigh before eating or drinking) and then self-report weight using the Fitbit app where it can be later exported by research staff. Participants will be required to self-weigh using a reliable, digital wireless scale that can estimate weight to the nearest tenth of a pound. Percent weight loss at week 12 will be calculated as the percentage loss in initial body weight at baseline by the time of the post-treatment assessment.

次要结局

  • Change in Week 3 Utilization of DSM for Dietary Change at Week 12(Week 3, Week 12 (Post-Treatment))
  • Change in Baseline Attitudes Towards DSM at Week 12(Week 0 (Baseline), Week 12 (Post-Treatment))
  • Perceived Autonomy Support at Week 12(Week 12 (Post-Treatment))
  • Change in Weekly Compliance with DSM from Weeks 1 to 12(Week 1 through Week 12 (Post-Treatment))
  • Change in Week 3 Utilization of Strategies to Ensure DSM Accuracy at Week 12(Week 3, Week 12 (Post-Treatment))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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