A Brief Web-Based and Mobile Intervention of Intermittent Fasting With Meal Support for Weight Loss Among Adults With Overweight and Obesity in Japan: Pilot Randomized Controlled Trial
Bibliographic record
Abstract
Background Intermittent fasting emerges as a promising dietary approach against obesity, offering a cost-effective strategy for implementation via web-based platforms. We developed a Brief Online Intermittent Fasting Program (OIF), featuring a self-administered, weekly 1-day fasting regimen with replacement meals delivery, online guidance, and app messaging to support adherence. Objective This pilot study aimed to assess the preliminary effectiveness, feasibility, and safety of the OIF on weight loss in adults with overweight and obesity in Japan. Secondary objectives were to assess its effects on body composition and metabolic markers. Methods This 12-week, 1:1 randomized controlled trial recruited adults with overweight and obesity (BMI from 23 to <35) in 1 university, 1 hospital, and 2 company offices. Participants were randomized into 2 groups stratified by sex and age (<40 or ≥40 years). The intervention group received very low-calorie (407 kcal) meal replacements for weekly intermittent fasting, online guidance via Zoom (Zoom Video Communications, Inc), and app messages encouraging fasting and healthy lifestyles. The control group received app messages promoting healthy lifestyles only. Interventions were administered by a nonblinded researcher. The primary outcome was the change in body weight after 12 weeks, analyzed using intention-to-treat principles and adjusted for sex, age, and baseline weight. Secondary outcomes encompassed body composition, blood pressure, biomarkers (eg, hemoglobin A1c, triglycerides, and cholesterol), quality of life, physical activity, intervention adherence, and adverse events. Results A total of 57 individuals were enrolled (28 in the intervention group and 29 in the control group). At 12 weeks, 25 participants in the intervention group and 27 participants in the control group completed follow-up. The baseline median weight was 75.8 (IQR 68.3-80.6) kg for the intervention group and 74.8 (IQR 69.8-81.8) kg for the control group. The mean weight change was –0.9 (SD 1.9) kg in the intervention group and +0.6 (SD 1.4) kg in the control group. The adjusted between-group difference in weight change was statistically significant at –1.6 (95% CI –2.5 to –0.8) kg. Fat mass change was not statistically significant (–0.1, 95% CI –1.3 to 1.4 kg), but muscle mass reduction was implied (–1.3, 95% CI –2.5 to –0.2 kg). Intervention adherence was 79% (22/28) in the intervention group. No serious adverse events were reported, and there were no significant changes in key biomarkers, such as hemoglobin A1c or quality of life. Conclusions The OIF demonstrated effectiveness in promoting modest weight loss among adults with overweight and obesity over 12 weeks, with high feasibility and safety indicated by low dropout rates and absence of serious adverse events. However, the observed reduction in muscle mass indicates a need for program refinement, such as incorporating exercise guidance, to optimize health outcomes. Trial Registration UMIN-CTR UMIN000050437; https://tinyurl.com/4x5h2t2x
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".