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Study on Low-Calorie vs. Intermittent Fasting with Lifestyle Coaching for Effective Weight Management

Effectiveness of Low-Calorie Diet versus Intermittent Fasting, with and without Behavioral Interventions, on Weight Loss and Metabolic Health: A Randomized Controlled Trial - WEIGHT-BEAM Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070430
Enrollment
200
Registered
2024-07-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E66- Overweight and obesity

Interventions

Intervention1: Intermittent fasting with behavioral intervension: Intermittent fasting with 16 hours fasting/8 hours eating window with behavioral intervention, will be administered for a duration of

Sponsors

Goverment MLB Gilrs PG College Indore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 to 60 years. Body mass index (BMI) between 25 and 40 kg/m². Generally healthy without significant acute or chronic illnesses that could interfere with diet adherence or affect study outcomes. Willing and able to comply with the diet protocols and follow-up assessments for the duration of the study. Able to provide written informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Significant psychiatric disorders, pregnancy or breastfeeding. 2. Chronic diseases such as cardiovascular conditions. 3. Diabetes (Type 1 or Type 2) as their management could interfere with the dietary interventions planned in the study. 4. bariatric surgery

Design outcomes

Primary

MeasureTime frame
Change in body weight from baseline to 12 months.Timepoint: Change in body weight from baseline to 12 months.

Secondary

MeasureTime frame
lean mass.Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;blood pressure (both systolic and diastolic)Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;body fat percentageTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;cardiorespiratory fitness.Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;fat massTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;general health perception.Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;glycated hemoglobin (HbA1c) levelsTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;lipid profiles, including cholesterol and triglyceridesTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;Matsuda indexTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;physical functioning. and emotional well-being.Timepoint: baseline, 3 months, 6 months, 9 months, 12 months;resting heart rateTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;waist circumferenceTimepoint: baseline, 3 months, 6 months, 9 months, 12 months;waist-to-hip ratioTimepoint: baseline, 3 months, 6 months, 9 months, 12 months

Countries

India

Contacts

Public ContactAmit Kumar Soni

Government MLB GIrls college indore

amit.soni7@gmail.com9926638661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026