LIHT: Testing the Effect of Multiple Weight Management Modalities for Chronic Disease Risk Reduction in a Clinical Setting
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Rate of Recruitment [1 year]
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
- Rate of Retention [1 year]
Feasibility of retaining participants in a randomized dietary intervention in a clinic setting as measured by the number of participants completing all study visits
- Adherence to the Intervention [1 year]
Feasibility of maintaining participant adherence in a randomized dietary intervention in a clinic setting will be measured by attendance at scheduled clinic visits
- Change in Weight [baseline to 3 months]
Participant weight will be measured
- Change in BMI [baseline to 3 months]
Participant BMI will be measured
- Change in HbA1c [baseline to 3 months]
Participant HbA1c will be measured
- Change in Fasting Glucose [baseline to 3 months]
Participant fasting glucose will be measured
- Change in Fasting Insulin [baseline to 3 months]
Participant fasting insulin will be measured
- Change in Total Cholesterol [baseline to 3 months]
Participant total cholesterol will be measured
- Change in Triglycerides [baseline to 3 months]
Participant triglycerides will be measured
- Change in High Density Lipoprotein (HDL) [baseline to 3 months]
Participant HDL will be measured
- Change in Low Density Lipoprotein (LDL) [baseline to 3 months]
Participant LDL will be measured
- Change in C-Reactive Protein (CRP) [baseline to 3 months]
Participant CRP will be measured
- Change in Insulin-like Growth Factor 1 (IGF-1) [baseline to 3 months]
Participant IGF-1 will be measured
- Change in Insulin-like Growth Factor 2 (IGF-2) [baseline to 3 months]
Participant IGF-2 will be measured
- Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) [baseline to 3 months]
Participant IGFBP-3 will be measured
- Change in Leptin [baseline to 3 months]
Participant leptin will be measured
- Change in Adiponectin [baseline to 3 months]
Participant adiponectin will be measured
- Participant Satisfaction [3 months]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arizona | Tucson | Arizona | United States | 85714 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1903480167