Regulation of Energy Balance and Metabolism - Mechanisms Behind and Beyond Obesity and Weight Loss

NCT03550339 | Completed

• 1 other identifier: 327/2016
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate homeostatic and hedonic mechanisms regulating appetite, energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms.

Conditions

Obesity; Appetitive Behavior

Keywords

obesity; appetite; food reward; hormonal responses; psychophysiological responses; implicit measures; explicit measures

Outcome Measures

Primary Outcomes (2)

• Implicit associations

  D-score of Implicit Association Test

  Change from baseline D-score at 1 year

• Explicit ratings

  Ratings on visual analogue scales for wanting and liking of presented foods

  Change from baseline visual analogue scale at 1 year

Secondary Outcomes (10)

• Event-related potentials

  Change from baseline event-related potentials at 1 year

• Glucose

  Change from baseline glucose at 1 year

• Insulin

  Change from baseline insulin at 1 year

• Ghrelin

  Change from baseline ghrelin at 1 year

• Leptin

  Change from baseline leptin at 1 year

Study Arms (3)

SURG

ACTIVE COMPARATOR

subjects attending bariatric surgery

Procedure: SURG

DIET

ACTIVE COMPARATOR

subjects attending dietary weight loss program

Behavioral: DIET

HAES

ACTIVE COMPARATOR

subjects attending Health At Every Size weight management program

Behavioral: HAES

Interventions

SURG PROCEDURE

bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults

SURG

DIET BEHAVIORAL

dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults

DIET

HAES BEHAVIORAL

treatment is based on the previously published procedure (e.g. Bacon et al. 2002) and Health At Every Size trademark, consisting of body acceptance, eating behaviour, physical activity, nutrition, and social support

HAES

Eligibility Criteria

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

You may qualify if:

• body mass index \>34 kg/m2
• native finnish speaker
• right-handed

You may not qualify if:

• pregnancy or breast feeding
• severe visual impairments, severe scalp skin lesions or intracranial bleeding during previous six months
• severe neurological, psychiatric or cardiovascular disease
• type 1 or 2 diabetes mellitus
• use of weight loss medications or other treatments known to affect weight
• heavy alcohol use
• any other condition (medical or other) the principal investigator considers as an obstacle to participation

Sponsors & Collaborators

• University of Eastern Finland: lead
• VTT Technical Research Centre of Finland: collaborator
• Kuopio University Hospital: collaborator
• Alfido Ltd: collaborator

MeSH Terms

Conditions

Obesity; Appetitive Behavior

Interventions

Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Leila J Karhunen, PhD

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: June 8, 2018
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share