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The TREND Study: Tapered Reduction in Energy Intake as a Novel Approach to Dieting

NCT02837211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2018-08-21

No results posted yet for this study

Summary

TREND is a pilot randomized trial comparing two alternative methods of initiating a low-calorie weight loss diet. The study will compare the traditional diet initiation of abruptly dropping energy intake to 1000 kcal/day for women and 1200 kcal/day for men versus a 6 week tapering of energy intake from a baseline level. These two approaches will be compared with respect to their impact on energy regulatory systems of the body, weight loss and other measures, up to a year after diet initiation.

Conditions

Interventions

BEHAVIORAL

Tapered Low Calorie Diet

All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Tapered Diet Arm will undergo the following 24 week feeding study intervention. The difference between a participant's run-in period energy intake and low-calorie "prescribed" energy intake (1000 kcal for women; 1200kcal for men) will be divided by six. At weekly intervals from weeks 1-6, daily caloric intake will be decreased by this fixed amount, reaching the final daily caloric goal (1000 kcals for women and 1200 kcals for men) by the end of the 6th week. Participants will present twice per week during weeks 1-6 to receive food that sums to that week's prescribed calorie level. From weeks 7-24, these participants will then follow a traditional low-calorie diet, still presenting for food pickups twice per week at a stable caloric level during this period.

BEHAVIORAL

Traditional Low-Calorie Diet

All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Traditional Diet Arm will undergo the following 24 week feeding study intervention. Immediately following run-in, these participants will start a low-calorie diet (1000 kcal per day for women; 1200kcal for men) Participants will present twice per week during weeks 1-24 to receive food that sums to that week's prescribed calorie level.

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Kristina H Lewis, MD MPH SM · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-05-11
Completion
2018-05-11

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02837211 on ClinicalTrials.gov