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

University of Arizona

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Hunger Training; Behavioral: Low-Carbohydrate Diet; Behavioral: Intermittent Energy Restriction

Study type: Interventional

Funder types: Other

Identifiers

NCT03998878

1903480167

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Low-Carbohydrate Diet

Experimental group

Description:

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

Treatment:

Behavioral: Low-Carbohydrate Diet

Intermittent Energy Restriction

Experimental group

Description:

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

Treatment:

Behavioral: Intermittent Energy Restriction

Hunger Training

Experimental group

Description:

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

Treatment:

Behavioral: Hunger Training