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Reduced-Calorie Diet for Obesity (Lower CD Trial)

N/A
Waitlist Available
Research Sponsored by The University of Tennessee, Knoxville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 18 and 65 years
Be older than 18 years old
Must not have
Report major psychiatric diseases or organic brain syndromes
Report being unable to walk for 2 blocks (1/4 mile) without stopping
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Summary

This trial found that reducing dietary energy density (the amount of calories per gram of food) may help people lose weight.

Who is the study for?
This trial is for adults aged 18-65 with a BMI of 27-45 kg/m2 who are not currently in a weight loss program or taking weight loss meds, haven't lost more than 5% body weight recently, don't have major heart conditions or psychiatric diseases, aren't pregnant or post-partum within six months, and can walk two blocks without stopping.
What is being tested?
The study tests whether eating foods low in energy density (calories relative to food weight) helps with weight loss. It explores if it's better to increase low-energy-dense foods like fruits and vegetables or decrease high-energy-dense foods like fats.
What are the potential side effects?
There may be no direct side effects from the dietary intervention itself; however, changes in diet could potentially lead to temporary digestive adjustments such as bloating or changes in bowel habits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a significant psychiatric condition or brain disorder.
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I can't walk 2 blocks without stopping.
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I have had or plan to have weight loss surgery soon.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
BMI
Dietary: Energy Density
Dietary: Energy Intake
+7 more
Secondary study objectives
Diet satisfaction
Other study objectives
Compliance

Trial Design

2Treatment groups
Active Control
Group I: COMBINATIONActive Control1 Intervention
This condition will be identical to the INCREASE condition, except it will also have a goal regarding the number of high-ED foods to consume and substituting low-ED foods for high-ED foods. Thus, this condition will have ED goals to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day. Foods with an ED \>1.0 kcal/g but \< 3.0 kcal/g will be unlimited; however, lower ED foods will be strongly encouraged. Furthermore, additions to beverages (i.e., sugar, cream) will count toward the \> 3.0 kcal/g goal if the additions meet that ED criteria.
Group II: INCREASEActive Control1 Intervention
This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) per day.

Find a Location

Who is running the clinical trial?

The University of Tennessee, KnoxvilleLead Sponsor
85 Previous Clinical Trials
18,682 Total Patients Enrolled
18 Trials studying Obesity
7,377 Patients Enrolled for Obesity

Media Library

Common components of intervention Clinical Trial Eligibility Overview. Trial Name: NCT02674971 — N/A
Obesity Research Study Groups: COMBINATION, INCREASE
Obesity Clinical Trial 2023: Common components of intervention Highlights & Side Effects. Trial Name: NCT02674971 — N/A
Common components of intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT02674971 — N/A
~1 spots leftby Dec 2024
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