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OpenTrials
Completed

NCT Number: NCT03696966

KU Alternate Meal Energy Level Study

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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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 21-65 years.
  • 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.
  • Clearance for participation from their PCP.

Exclusion criteria

  • 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.
  • Participation in a regular exercise program (i.e., > 500 kcal/wk. of planned activity as estimated by questionnaire [34].
  • 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
  • Unwilling to be randomized to one of two diet strategies for weight loss.
  • Pregnant during the previous 6 mos., lactating, or planned pregnancy in the following 6 mos.
  • Serious medical risk (e.g. diabetes, cancer, cardiovascular disease) as determined by the individual's physician via the clearance to participate in the investigation.
  • 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.
  • Current treatment for psychological problems, or taking psychotropic medications. Addressing psychological problems is outside the scope of this study.
  • Medications known to significantly influence weight.
  • Adherence to specialized diet regimens (e.g., multiple food allergies, vegan, etc.)
  • Do not have access to or independence over grocery shopping and meal preparation (i.e. those in military, college with cafeteria plan, etc.).
  • If participants have recently undergone CT (Computed Tomography), PET, fluoroscopic, or nuclear medicine studies within the past year.

Treatment and study plan

Portion-Controlled Meals

Dietary Supplement

Increase dietary structure using portion-controlled meals (PCM)

Low-calorie diet

Behavioral

Restrict calorie intake daily

Intermittent Very-Low Calorie Diet

Behavioral

Severely restrict calorie intake intermittently

Other names: Intermittent Fasting

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: KAMEL

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 5, 2018
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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