KU Alternate Meal Energy Level Study

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Debra K. Sullivan, PhD, RD，University of Kansas Medical Center

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

January 16, 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

KU Alternate Meal Energy Level Study

Official Title ^ICMJE

KU Alternate Meal Energy Level Study

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 Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Dietary Supplement: Portion-Controlled Meals
Increase dietary structure using portion-controlled meals (PCM)
Behavioral: Low-Calorie Diet
Restrict calorie intake daily
Behavioral: Intermittent Very-Low Calorie Diet
Severely restrict calorie intake intermittently

Study Arms

Active Comparator: Continuous Calorie Restriction
Daily calorie restriction: follow low-calorie diet (1,200-1,500 calories) daily using portion-controlled meals
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

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2018

Estimated Primary Completion Date

October 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Debra K. Sullivan, PhD, RD，University of Kansas Medical Center

Study Sponsor ^ICMJE

University of Kansas Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

University of Kansas Medical Center

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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