Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/05/2016
Date assigned
16/05/2016
Last edited
16/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A low-calorie, low-fat, high-carbohydrate diet is the recommended diet for the treatment of obesity because it helps with weight loss. This recommendation has been recently challenged by studies showing that low-carbohydrate diets might result in greater weight loss at 6 months. However, in the longer term (1-2 years) weight loss is modest with both approaches, and the advantages of low-carbohydrate diets on weight loss are not universally demonstrated. For this reason we aim to evaluate the effects of long-term (1 year) reduced calorie intake associated with different type of diets (high-protein and high-carbohydrate diets with a similar amount of energy from fats and saturated fats).

Who can participate?
Patients aged 18-65 with severe obesity

What does the study involve?
Participants are randomly allocated to consume either a high-protein diet or a high-carbohydrate diet. All participants receive Cognitive Behaviour Therapy (CBT), education about diet and exercise, and attend exercise sessions.

What are the possible benefits and risks of participating?
We expect that both groups should lose weight and decrease their risk of heart disease. Possible risks are not known.

Where is the study run from?
Villa Garda Hospital (UK)

When is the study starting and how long is it expected to run for?
June 2007 to January 2011

Who is funding the study?
Villa Garda Hospital (Italy)

Who is the main contact?
Dr Riccardo Dalle Grave

Trial website

Contact information

Type

Scientific

Primary contact

Dr Riccardo Dalle Grave

ORCID ID

Contact details

Monte Baldo Street
89
Garda
37016
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

USL22#01/07-CEP31

Study information

Scientific title

A randomized trial of energy-restricted high-protein versus high-carbohydrate, low-fat diet in morbid obesity

Acronym

Study hypothesis

No difference will be found between the two types of diet in patients with severe obesity assessed at inpatient admission, and after 27 weeks and 1 year

Ethics approval

The ethical committee of the Local Health Unit 22-Bussolengo, 19/06/2007, Study Protocol no. USL22#01/07-CEP31

Study design

Randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Class II and III obesity

Intervention

The treatment was divided into two stages: Stage One (inpatient treatment; 3 weeks); Stage Two (outpatient treatment; 48 weeks).

Participants started the assigned diet on the second inpatient day, and continued it during the whole Stage Two. They were admitted in consecutive blocks of 8, all following the same diet, to avoid exchanges between participants allocated to different diets. Both diets were energy-restricted (1,200 kcal/day for women and 1,500 kcal/day for men), with 20% energy from fats (<10% from saturated fats) and daily multivitamin supplements. The high-protein diet (HPD) derived 34% energy from proteins and 46% from carbohydrates, whereas the high-carbohydrate diet (HCD) had 17% energy from proteins and 63% from carbohydrates.

Cognitive Behaviour Therapy (CBT) intervention
All participants received a comprehensive manual-based CBT to enhance the adherence to lifestyle modification integrating education with cognitive behavioural procedures and strategies. Stage One included 15 CBT groups (five a week), chaired by physicians, dieticians and psychologists, 18 sessions of aerobic exercises (e.g., 30 min of tapis roulant or cyclette) and six sessions callisthenic, chaired by physical trainers. Education addressed the following main topics:
1. Energy balance
2. The food pyramid, size of portions and regular eating
3. Calorie counting
4. Shopping and food labels
5. Physical activity, when and how much.

The cognitive behavioural procedures and strategies included:
1. Self-monitoring of food intake, energy and body weight
2. Stimulus control strategies (in particular how to reduce food stimuli at home)
3. Problem solving
4. Cognitive restructuring of dysfunctional thoughts that hinder weight loss and weight loss maintenance
5. Relapse prevention.

Stage Two included 12 sessions of 45 min each over 48 weeks with a CBT-trained dietician. The first 4 sessions were carried out every 2 weeks, followed by 4 sessions every 4 weeks and then by 4 sessions every 6 weeks in the last 24 weeks. Every session had the following content:
1. Weighing the patient and recording on a graph
2. Checking home weight control
3. Reviewing the self-monitoring record of food and drink intake and of number of daily steps assessed by a pedometer
4. Setting the agenda collaboratively
5. Working through agenda topics
6. Agreeing on new homework assignments
7. Summarizing the session.

The first 24 weeks of stage two (27 weeks from treatment start) were dedicated to address barriers to weight loss, the remaining sessions to weight maintenance. In this last phase the calorie content was gradually increased to maintain the weight, without changes in macronutrient composition.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Percent weight loss at study end (1 year)

Secondary outcome measures

The secondary outcomes were assessed at baseline, after 3 weeks, after 27 weeks and after 1 year.
1. Attrition rates
2. Cardiovascular risk factors and psychological profile, measured using:
2.1. The Body Uneasiness Test-A
2.2. The Binge Eating test
2.3. Beck Depression Inventory
2.4. Beck Anxiety Inventory

Overall trial start date

19/06/2007

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age range 18-65 years
2. Body mass index (BMI) ≥ 40.0 kg/m2 or between 35 and 39.9 with at least one weight loss-responsive comorbidity (e.g., type 2 diabetes, cardiovascular diseases, sleep apnea, severe joint disease, two or more risk factors defined by the Adult Treatment Panel III)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

88 patients with obesity, 44 for each type of diet

Participant exclusion criteria

1. Pregnancy or lactating
2. Took medications affecting body weight
3. Medical comorbidities associated with weight loss or had severe psychiatric disorders (e.g., acute psychotic states, bipolar disorder, bulimia nervosa)

Recruitment start date

01/09/2007

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Italy

Trial participating centre

Villa Garda Hospital
Department of Eating Disorder and Obesity
37016
Italy

Sponsor information

Organisation

Regional Agency for Health and Social Care, Regione Emilia-Romagna (Italy)

Sponsor details

Aldo Moro Street 21
Bologna
40127
Italy

Sponsor type

Government

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Villa Garda Hospital (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes