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

NCT03998878 | Completed

• 1 other identifier: 1903480167
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight Loss; Diet Modification; Body Weight; Body Weight Changes; Ketogenic diet; Diet, Carbohydrate-Restricted; Fasting; Intermittent Fasting; Hunger training

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (3)

Low-Carbohydrate Diet

EXPERIMENTAL

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

Behavioral: Low-Carbohydrate Diet

Intermittent Energy Restriction

EXPERIMENTAL

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

Behavioral: Intermittent Energy Restriction

Hunger Training

EXPERIMENTAL

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

Behavioral: Hunger Training

Interventions

Low-Carbohydrate Diet BEHAVIORAL

Participants will be instructed to follow a low-carbohydrate diet.

Low-Carbohydrate Diet

Intermittent Energy Restriction BEHAVIORAL

Participants will be instructed to follow intermittent energy restriction.

Intermittent Energy Restriction

Hunger Training BEHAVIORAL

Participants will be instructed to follow Hunger Training.

Hunger Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight/obese as indicated by BMI \>27
• Age ≥ 18
• HbA1C \<8.0
• Fluent in English

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85714, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss; Body Weight; Body Weight Changes; Fasting; Intermittent Fasting

Interventions

Diet, Carbohydrate-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Amit Algotar, MD, PhD, MPH

  University of Arizona, Banner University Medical Center

  PRINCIPAL INVESTIGATOR

• Susan M Schembre, PhD, RD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 26, 2019
• Study Start: August 8, 2019
• Primary Completion: December 16, 2021
• Study Completion: December 16, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

US (1)