KU Alternate Meal Energy Level Study

Not Applicable

Completed

• Conditions: Weight Loss; Obesity
• Interventions: Dietary Supplement: Portion-Controlled Meals; Behavioral: Intermittent Very-Low Calorie Diet; Behavioral: Low-Calorie Diet

• Registration Number: NCT03696966
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2018-01-16
• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-10-03
• Primary Completion: 2018-10-04
• Study First Posted: 2018-10-05
• Study Completion: 2018-11-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. Age 21-65 years.
2. BMI 25-35. Patients with a BMI less than 25 are not classified as overweight and individuals with a BMI >35 may require more aggressive weight management strategies.
3. Clearance for participation from their PCP.

Exclusion Criteria

1. Participation in a research project or formal program involving weight loss or exercise in the previous 6 mos., as these proximal experiences may impact the results of this study.
2. Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34].
3. Not weight stable (-/+ 5%) for 6 mos. prior to intake. This will be determined by phone screen and self-report on the health history questionnaire
4. Unwilling to be randomized to one of two diet strategies for weight loss.
5. Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
6. Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
7. Disordered eating as determined by the Eating Attitudes Test using a score of 20 or greater [35]. This score indicates the need for counseling outside the scope of this study.
8. Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
9. Medications known to significantly influence weight.
10. Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
11. Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
12. If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Calorie Restriction	Portion-Controlled Meals	Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals
Intermittent Very-Low Calorie Diet	Intermittent Very-Low Calorie Diet	Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days
Intermittent Very-Low Calorie Diet	Portion-Controlled Meals	Intermittent Restriction: follow very-low calorie diet (500-800) with portion-controlled meals three days per week and structured healthy eating on other days
Continuous Calorie Restriction	Low-Calorie Diet	Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals

Primary Outcome Measures

Name	Time	Method
Body composition	Change from baseline to 24 weeks	Change in absolute (g) and relative (%) fat mass and fat-free mass from baseline to 24 weeks
Weight (lbs, % change from baseline)	Change from baseline to 24 weeks	Change in absolute (lbs) and relative (%) weight from baseline to the end of the intervention (24 weeks)

Secondary Outcome Measures

Name	Time	Method
Program adherence	weekly through study completion (24 weeks)	Compliance to intervention protocol; adherence = (# attained / # expected)\*100
Nutrition-related quality of life	baseline, week 12, week 24	Assessed via questionnaire; higher scores indicate greater nutrition-related quality of life.
Dietary restraint	baseline, week 12, week 24	Assessed via three-factor eating questionnaire with three component scores for cognitive restraint, disinhibition, hunger)

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States