| CTRI Number |
CTRI/2024/07/070430 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Study on Low-Calorie vs. Intermittent Fasting with Lifestyle Coaching for Effective Weight Management |
|
Scientific Title of Study
|
Effectiveness of Low-Calorie Diet versus Intermittent Fasting, with and without Behavioral Interventions, on Weight Loss and Metabolic Health: A Randomized Controlled Trial |
| Trial Acronym |
WEIGHT-BEAM Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Kumar Soni |
| Designation |
Assistant professor |
| Affiliation |
Government MLB GIrls college indore |
| Address |
Department of psychology
VIP road,
Kila maidan
indore M.P. 452006
Indore
MADHYA PRADESH
452006
India |
| Phone |
9926638661 |
| Fax |
|
| Email |
amit.soni7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amit Kumar Soni |
| Designation |
Assistant professor |
| Affiliation |
Government MLB GIrls college indore |
| Address |
Department of psychology
VIP road,
Kila maidan
indore M.P. 452006
Indore
MADHYA PRADESH
452006
India |
| Phone |
9926638661 |
| Fax |
|
| Email |
amit.soni7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit Kumar Soni |
| Designation |
Assistant professor |
| Affiliation |
Government MLB GIrls college indore |
| Address |
Department of psychology
VIP road,
Kila maidan
indore M.P. 452006
Indore
MADHYA PRADESH
452006
India |
| Phone |
9926638661 |
| Fax |
|
| Email |
amit.soni7@gmail.com |
|
|
Source of Monetary or Material Support
|
| goverment MLB Gilrs pg college, VIP road, Kila Maidan,Indore MP 452006 |
|
|
Primary Sponsor
|
| Name |
Goverment MLB Gilrs PG College Indore |
| Address |
VIP road,
Kila Maidan
Indore M.P. India 452006 |
| Type of Sponsor |
Other [Goverment run Educational institute / college] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amit Kumar Soni |
Government MLB Girls PG College, Indore |
Deaprtment of Psychology,
Government MLB Girls PG College,
VIP road, Kila bhawan, Indore M.P. 452006
Indore
MADHYA PRADESH |
9926638661
amit.soni7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E66||Overweight and obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low-calorie diet |
Low-calorie diet with 1200-1500 kcal per day without any kind of behavioral intervention, will be administered for a duration of 12 months |
| Comparator Agent |
Low-calorie diet with behavioural intervention |
Low-calorie diet 1200-1500 kcal per day with behavioral intervention, will be administered for a duration of 12 months. |
| Comparator Agent |
Intermittent fasting |
Intermittent fasting 16 hours fasting per 8 hours eating window without behavioral intervention, will be administered for a duration of 12 months |
| Intervention |
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 12 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in body weight from baseline to 12 months. |
Change in body weight from baseline to 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fat mass |
baseline, 3 months, 6 months, 9 months, 12 months |
| lean mass. |
baseline, 3 months, 6 months, 9 months, 12 months |
| body fat percentage |
baseline, 3 months, 6 months, 9 months, 12 months |
| waist circumference |
baseline, 3 months, 6 months, 9 months, 12 months |
| waist-to-hip ratio |
baseline, 3 months, 6 months, 9 months, 12 months |
| glycated hemoglobin (HbA1c) levels |
baseline, 3 months, 6 months, 9 months, 12 months |
| blood pressure (both systolic and diastolic) |
baseline, 3 months, 6 months, 9 months, 12 months |
| lipid profiles, including cholesterol and triglycerides |
baseline, 3 months, 6 months, 9 months, 12 months |
| resting heart rate |
baseline, 3 months, 6 months, 9 months, 12 months |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). |
baseline, 3 months, 6 months, 9 months, 12 months |
| Matsuda index |
baseline, 3 months, 6 months, 9 months, 12 months |
| cardiorespiratory fitness. |
baseline, 3 months, 6 months, 9 months, 12 months |
| general health perception. |
baseline, 3 months, 6 months, 9 months, 12 months |
physical functioning.
and emotional well-being. |
baseline, 3 months, 6 months, 9 months, 12 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The WEIGHT-BEAM Study is an extensive randomized controlled trial designed to assess the effectiveness of two different dietary strategies—low-calorie diet and intermittent fasting—each implemented with and without additional behavioral interventions, in a larger population of 200 adults aged between 18 and 60 years, who have a body mass index (BMI) ranging from 24 to 40 kg/m². This study aims to provide insights into which diet method is more effective for sustainable weight loss and improving various metabolic health outcomes. Over a 12-month period of active intervention followed by a 6-month follow-up phase without intervention, the study will monitor a variety of outcomes to understand the impact of these diets not only on weight loss but also on a broad spectrum of health parameters. These parameters include body composition changes such as fat mass and lean mass, metabolic health indicators like waist circumference, waist-to-hip ratio, and glycated hemoglobin levels. Moreover, the study will explore changes in lipid profiles, blood pressure, resting heart rate, and insulin resistance, measured through HOMA-IR and the Matsuda index. Additionally, the trial will assess improvements in cardiorespiratory fitness, as well as psychological well-being, including general health perception, physical functioning, and emotional health. The inclusion of behavioral interventions aims to explore whether consistent coaching and psychological support can enhance the efficacy of these diets and promote better adherence to lifestyle changes. By increasing the number of participants to 200, the study seeks to enhance the statistical power to detect meaningful differences between the interventions, thus providing more reliable conclusions. These insights are crucial for developing targeted dietary recommendations and public health policies aimed at combating obesity and its associated health risks. The comprehensive data collected will help delineate the nuanced effects of diet and behavior on long-term weight management and overall health improvement. |