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

Obesity Clinical Trial

— LIHT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03998878
• Other study ID #: 1903480167
• Status: Completed
• Phase: N/A
• Start date: August 8, 2019
• Est. completion date: December 16, 2021

Study information

• Verified date: December 2021
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 16, 2021
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Obesity

Intervention

Behavioral:
• Low-Carbohydrate Diet
Participants will be instructed to follow a low-carbohydrate diet.
• Intermittent Energy Restriction
Participants will be instructed to follow intermittent energy restriction.
• Hunger Training
Participants will be instructed to follow Hunger Training.

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in Weight	Participant weight will be measured	baseline to 3 months
Primary	Change in BMI	Participant BMI will be measured	baseline to 3 months
Primary	Change in HbA1c	Participant HbA1c will be measured	baseline to 3 months
Primary	Change in Fasting Glucose	Participant fasting glucose will be measured	baseline to 3 months
Primary	Change in Fasting Insulin	Participant fasting insulin will be measured	baseline to 3 months
Primary	Change in Total Cholesterol	Participant total cholesterol will be measured	baseline to 3 months
Primary	Change in Triglycerides	Participant triglycerides will be measured	baseline to 3 months
Primary	Change in High Density Lipoprotein (HDL)	Participant HDL will be measured	baseline to 3 months
Primary	Change in Low Density Lipoprotein (LDL)	Participant LDL will be measured	baseline to 3 months
Primary	Change in C-Reactive Protein (CRP)	Participant CRP will be measured	baseline to 3 months
Primary	Change in Insulin-like Growth Factor 1 (IGF-1)	Participant IGF-1 will be measured	baseline to 3 months
Primary	Change in Insulin-like Growth Factor 2 (IGF-2)	Participant IGF-2 will be measured	baseline to 3 months
Primary	Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)	Participant IGFBP-3 will be measured	baseline to 3 months
Primary	Change in Leptin	Participant leptin will be measured	baseline to 3 months
Primary	Change in Adiponectin	Participant adiponectin will be measured	baseline to 3 months
Primary	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