KU Alternate Meal Energy Level Study (KAMEL)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Weight Loss
• Intervention / Treatment: Dietary supplement: Portion-Controlled Meals; Behavioral: Low-Calorie Diet; Behavioral: Intermittent Very-Low Calorie Diet

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Continuous Calorie Restriction; Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals	Dietary supplement: Portion-Controlled Meals; Increase dietary structure using portion-controlled meals (PCM); Behavioral: Low-Calorie Diet; Restrict calorie intake daily
EXPERIMENTAL: 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	Dietary supplement: Portion-Controlled Meals; Increase dietary structure using portion-controlled meals (PCM); Behavioral: Intermittent Very-Low Calorie Diet; Severely restrict calorie intake intermittently; Other Names: Intermittent Fasting

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2018
• Primary Completion (ACTUAL): October 4, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (ACTUAL): October 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: obesity; weight management; very-low calorie diet; intermittent diet
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: IRB_STUDY00141322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No