University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT03696966
Compare intermittent versus continuous calorie restriction to learn more about these eating plans and determine whether they are useful and effective to lose weight and keep it off.
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Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
The purpose of this study is to provide evidence for the feasibility of an alternative weight control strategy by comparing two diets to see how intermittent calorie restriction compares to continuous or daily calorie restriction for weight loss in 35 adults with overweight or obesity. These diets will be incorporated into a comprehensive and intensive weight management program involving weekly health education meetings, regular diet and physical activity tracking, and feedback from a registered dietitian.
Each intervention includes 3 months of weight loss and 3 months of weight maintenance.
Group 1: Follow a low-calorie diet every day (1,200 - 1,500 calories daily)
Group 2: Follow an intermittent very-low calorie diet (500-800 calories). Participants in this group will alternate between days of 500-800 calories and days of structured eating using healthy eating principles.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increase dietary structure using portion-controlled meals (PCM)
Restrict calorie intake daily
Severely restrict calorie intake intermittently
Other names: Intermittent Fasting
Time frame: Change from baseline to 24 weeks
Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)
Time frame: Change from baseline to 24 weeks
Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks
Time frame: weekly through study completion (24 weeks)
Compliance to intervention protocol; adherence = (# attained / # expected)*100
Time frame: baseline, week 12, week 24
Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.
Time frame: baseline, week 12, week 24
Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)
University of Kansas Medical Center
Other
Acronym: KAMEL
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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