KU Alternate Meal Energy Level Study (KAMEL)

• ClinicalTrials.gov Identifier: NCT03696966
• Recruitment Status: Completed
• First Posted: October 5, 2018
• Last Update Posted: January 22, 2019
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): Debra K. Sullivan, PhD, RD, University of Kansas Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity; Weight Loss	Dietary Supplement: Portion-Controlled Meals; Behavioral: Low-Calorie Diet; Behavioral: Intermittent Very-Low Calorie Diet	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: KU Alternate Meal Energy Level Study
• Actual Study Start Date: January 16, 2018
• Actual Primary Completion Date: October 4, 2018
• Actual Study Completion Date: November 1, 2018

Arms and Interventions

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 Name: Intermittent Fasting

Outcome Measures

Primary Outcome Measures :

1. Weight (lbs, % change from baseline) [ 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)
2. Body composition [ 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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Kansas

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Sponsors and Collaborators

University of Kansas Medical Center

Investigators

• Principal Investigator: Debra Sullivan, PhD, RD; University of Kansas Medical Center

More Information

• Responsible Party: Debra K. Sullivan, PhD, RD, Professor, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT03696966
• Other Study ID Numbers: IRB_STUDY00141322
• First Posted: October 5, 2018
• Last Update Posted: January 22, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Debra K. Sullivan, PhD, RD, University of Kansas Medical Center:

weight management; obesity; very-low calorie diet; intermittent diet

Additional relevant MeSH terms:

Weight Loss; Body Weight; Body Weight Changes