Clinical trial NCT03998878: Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting
Official title: Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting (LIHT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight Loss
Diet Modification
Body Weight
Body Weight Changes
Ketogenic diet
Diet, Carbohydrate-Restricted
Fasting
Intermittent Fasting
Hunger training
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of Recruitment
timeFrame: 1 year
measure: Rate of Retention
timeFrame: 1 year
measure: Adherence to the Intervention
timeFrame: 1 year
measure: Change in Weight
timeFrame: baseline to 3 months
measure: Change in BMI
timeFrame: baseline to 3 months
measure: Change in HbA1c
timeFrame: baseline to 3 months
measure: Change in Fasting Glucose
timeFrame: baseline to 3 months
measure: Change in Fasting Insulin
timeFrame: baseline to 3 months
measure: Change in Total Cholesterol
timeFrame: baseline to 3 months
measure: Change in Triglycerides
timeFrame: baseline to 3 months
measure: Change in High Density Lipoprotein (HDL)
timeFrame: baseline to 3 months
measure: Change in Low Density Lipoprotein (LDL)
timeFrame: baseline to 3 months
measure: Change in C-Reactive Protein (CRP)
timeFrame: baseline to 3 months
measure: Change in Insulin-like Growth Factor 1 (IGF-1)
timeFrame: baseline to 3 months
measure: Change in Insulin-like Growth Factor 2 (IGF-2)
timeFrame: baseline to 3 months
measure: Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
timeFrame: baseline to 3 months
measure: Change in Leptin
timeFrame: baseline to 3 months
measure: Change in Adiponectin
timeFrame: baseline to 3 months
measure: Participant Satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona, Banner University Medical Center
name: Amit Algotar, MD, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arizona
name: Susan M Schembre, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References: