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Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting

NCT ID: NCT03998878

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2021-12-16

Brief Summary

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This project will test 3 methods of dietary changes in a weight loss clinic. Participants will be randomized to one of 3 arms: low-carbohydrate diet, intermittent energy restriction, or Hunger Training. A maximum of 30 participants will be assigned to each arm. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic.

Detailed Description

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Adult obesity, a common condition in the United States, is a well-established risk factor for the development of chronic diseases, including diabetes, heart disease, hypertension, and many types of cancer. However, research has not determined what type of diet is best for reducing weight and achieving optimal health outcomes. In this randomized trial, participants seeking care at a weight loss clinic will be assigned to one of three diets: low-carbohydrate, intermittent energy restriction, or Hunger Training. On the low-carbohydrate diet, participants will be instructed to consume less than 30 grams of carbohydrates per day. The intermittent energy restriction protocol will require participants to choose 2 non-consecutive days per week in which they will consume 500-650 calories. Hunger Training is a relatively new approach that involves teaching people to monitor their hunger symptoms and blood glucose, and to eat only when blood glucose is below a certain level. To our knowledge, these weight loss modalities have not been compared in a single, clinical study. The goal of the proposed study is to determine the feasibility, early efficacy, and patient satisfaction of each weight loss modality in a population of patients seeking care at a weight loss clinic. The goal will be achieved though the successful completion of the following aims:

Aim 1: To determine the feasibility of recruiting, retaining and maintaining the adherence participants in a randomized clinical trial testing 3 weight loss modalities.

Aim 2: To examine and compare the effect of 3 weight loss modalities on changes in anthropometric measures and metabolic and cancer-related health markers.

Aim 3: To evaluate and compare patients' perceived satisfaction with each weight loss modality.

Conditions

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Obesity

Keywords

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Weight Loss Diet Modification Body Weight Body Weight Changes Ketogenic diet Diet, Carbohydrate-Restricted Fasting Intermittent Fasting Hunger training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low-Carbohydrate Diet

Participants will be instructed to consume less than 30 grams of carbohydrates per day.

Group Type EXPERIMENTAL

Low-Carbohydrate Diet

Intervention Type BEHAVIORAL

Participants will be instructed to follow a low-carbohydrate diet.

Intermittent Energy Restriction

Participants choose 2 non-consecutive days per week in which they will consume 500-650 calories.

Group Type EXPERIMENTAL

Intermittent Energy Restriction

Intervention Type BEHAVIORAL

Participants will be instructed to follow intermittent energy restriction.

Hunger Training

Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level.

Group Type EXPERIMENTAL

Hunger Training

Intervention Type BEHAVIORAL

Participants will be instructed to follow Hunger Training.

Interventions

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Low-Carbohydrate Diet

Participants will be instructed to follow a low-carbohydrate diet.

Intervention Type BEHAVIORAL

Intermittent Energy Restriction

Participants will be instructed to follow intermittent energy restriction.

Intervention Type BEHAVIORAL

Hunger Training

Participants will be instructed to follow Hunger Training.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Overweight/obese as indicated by BMI \>27
* Age ≥ 18
* HbA1C \<8.0
* Fluent in English

Exclusion Criteria

* Cognitive state that precludes informed consent or adherence to study protocols
* Pregnant, breast-feeding, or planning to become pregnant within 6 months
* A1C ≥ 8.0
* Taking an anti-obesity medication
* Insulin-dependence
* prior metabolic surgery
* current laparoscopic adjustable gastric band ("lap band") use
* Experience of substantial weight changes (±5 kg or ±10 lbs) in the past 3 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit Algotar, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Arizona, Banner University Medical Center

Susan M Schembre, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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1903480167

Identifier Type: -

Identifier Source: org_study_id