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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Appetitive Behavior
• Intervention / Treatment: Procedure: SURG; Behavioral: DIET; Behavioral: HAES

Detailed Description

Obesity is widely acknowledged health problem affecting millions of people globally. Enormous efforts have been made to solve the problem, but long-term results of the conventional weight loss and/or weight management strategies have been poor indicating still inadequate understanding of the problem. Surgical, rather than weight-centred lifestyle interventions, have proved to be the most effective tool available to treat obesity within individuals suitable for obesity surgery. Current surgical interventions are, however, suitable only for a small subset of obese individuals. In general, there is a need for development of new approaches and therapies that are safer and more individualized to each patient in the struggle against obesity and related disorders. To achieve these goals, research must focus to investigate and understand the complex homeostatic and hedonic regulation of eating behavior and energy balance in different physiological and pathological conditions.

This study aims to investigate homeostatic and hedonic mechanisms regulating energy balance and metabolism in obesity and the effects of three distinct obesity treatments on these regulatory mechanisms. The regulatory mechanisms are investigated at the level of metabolism, autonomic and central nervous systems as well as subjective, both implicit and explicit, experiences.

A total of 90 obese female volunteers (18-65 years, body mass index > 35 kg/m2), of which 30 females waiting for bariatric surgery (SURG), 30 females attending a dietary treatment program for obesity (DIET) and 30 females attending Health at Every Size (HAES) program, will participate in the study. The obesity treatment for SURG and DIET groups follows the principles of the Current Care Guidelines for Obesity (adults) and the treatment for the HAES group applies the strategies of the non-diet wellness-based HAES program. The treatment programs of the DIET and HAES groups include 8-10 weekly group sessions organized by authorised nutritionist.

The study includes also two four-hour visits at the research laboratory of the Institute of Public Health and Clinical Nutrition, University of Eastern Finland, the first visit organized before the participants attend any of the obesity treatments and the second visit 12 months later. During the laboratory visits psychophysiological signals (EEG, ANS, facial EMG and eye tracking) are monitored and blood samples taken throughout the experimental period. Participants will also perform two computer-based test sessions, the first one at baseline and the second before a snack meal. Two meals (breakfast and snack meal) are offered to the participants during the experiment in order to study the regulatory mechanisms of interest both at the homeostatic and hedonic states.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SURG; subjects attending bariatric surgery	Procedure: SURG; bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults
Active Comparator: DIET; subjects attending dietary weight loss program	Behavioral: DIET; dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults
Active Comparator: HAES; subjects attending Health At Every Size weight management program	Behavioral: HAES; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-related potentials	Event-related potentials measured by EEG	Change from baseline event-related potentials at 1 year
Glucose	Plasma glucose, fasting, postprandial	Change from baseline glucose at 1 year
Insulin	plasma insulin, fasting, postprandial	Change from baseline insulin at 1 year
Ghrelin	plasma ghrelin, fasting, postprandial	Change from baseline ghrelin at 1 year
Leptin	serum leptin, fasting	Change from baseline leptin at 1 year
Peptide YY	plasma peptide YY, fasting, postprandial	Change from baseline PYY at 1 year
Endocannabinoids	plasma endocannabinoids, fasting, postprandial	Change from baseline endocannabinoids at 1 year
Weight	body weight, fasting	Change from baseline weight at 1 year
Eating behaviour	self-reported questionnaires	Change from baseline eating behaviour at 1 year
Psychosocial characteristics	self-reported questionnaires	Change from baseline psychosocial characteristics at 1 year

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Collaborators: Kuopio University Hospital; VTT Technical Research Centre of Finland; Alfido Ltd
• Investigators: Principal Investigator: Leila J Karhunen, PhD, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: obesity; appetite; food reward; hormonal responses; psychophysiological responses; implicit measures; explicit measures
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss
• Other Study ID Numbers: 327/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No