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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Low-Carbohydrate Diet; Behavioral: Intermittent Energy Restriction; Behavioral: Hunger Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • University of Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Carbohydrate Diet; Participants will be instructed to consume less than 30 grams of carbohydrates per day.	Behavioral: Low-Carbohydrate Diet; Participants will be instructed to follow a low-carbohydrate diet.
Experimental: Intermittent Energy Restriction; Participants choose 2 non-consecutive days per week in which they will consume 500-650 calories.	Behavioral: Intermittent Energy Restriction; Participants will be instructed to follow intermittent energy restriction.
Experimental: Hunger Training; Participants monitor their hunger symptoms and blood glucose, and eat only when blood glucose is below a certain threshold level.	Behavioral: Hunger Training; Participants will be instructed to follow Hunger Training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Recruitment	Feasibility of recruiting participants into a randomized dietary intervention in a clinic setting as measured by the total number of individuals who are screened as eligible and enrolled into the study	1 year
Rate of Retention	Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits	1 year
Adherence to the Intervention	Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits	1 year
Change in Weight	Participant weight will be measured	baseline to 3 months
Change in BMI	Participant BMI will be measured	baseline to 3 months
Change in HbA1c	Participant HbA1c will be measured	baseline to 3 months
Change in Fasting Glucose	Participant fasting glucose will be measured	baseline to 3 months
Change in Fasting Insulin	Participant fasting insulin will be measured	baseline to 3 months
Change in Total Cholesterol	Participant total cholesterol will be measured	baseline to 3 months
Change in Triglycerides	Participant triglycerides will be measured	baseline to 3 months
Change in High Density Lipoprotein (HDL)	Participant HDL will be measured	baseline to 3 months
Change in Low Density Lipoprotein (LDL)	Participant LDL will be measured	baseline to 3 months
Change in C-Reactive Protein (CRP)	Participant CRP will be measured	baseline to 3 months
Change in Insulin-like Growth Factor 1 (IGF-1)	Participant IGF-1 will be measured	baseline to 3 months
Change in Insulin-like Growth Factor 2 (IGF-2)	Participant IGF-2 will be measured	baseline to 3 months
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)	Participant IGFBP-3 will be measured	baseline to 3 months
Change in Leptin	Participant leptin will be measured	baseline to 3 months
Change in Adiponectin	Participant adiponectin will be measured	baseline to 3 months
Participant Satisfaction	Participants will complete a questionnaire at the end of the study to assess the acceptability of and satisfaction with the weight loss diet intervention they received. We will assess overall satisfaction, enjoyment, likeliness to recommend, and ease of following the diet. Aggregated scores will be compared across weight loss modality.	3 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Amit Algotar, MD, PhD, MPH, University of Arizona, Banner University Medical Center; Principal Investigator: Susan M Schembre, PhD, RD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): December 16, 2021
• Study Completion (Actual): December 16, 2021

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Weight Loss; Body Weight; Fasting; Intermittent Fasting; Ketogenic diet; Diet Modification; Body Weight Changes; Diet, Carbohydrate-Restricted; Hunger training
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 1903480167

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No