Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Re-Feeding Duration on Weight Maintenance After Weight Loss With Very-Low-Energy Diets (VLEDs)

This study has been completed.
Sponsor:
Information provided by:
Göteborg University
ClinicalTrials.gov Identifier:
NCT00694811
First received: June 9, 2008
Last updated: June 10, 2008
Last verified: June 2008
  Purpose

The primary objective of the study is to test the hypothesis that prolonged re-feeding after VLED induced weight loss improves weight maintenance and eating behaviour


Condition Intervention Phase
Obesity
Behavioral: Re-feeding duration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Liquid Very-Low-Energy Diets (VLEDs) in Obesity Treatment. Effects of Re-Feeding Duration On Weight Maintenance, Eating Behaviour and Health-Related Quality of Life

Resource links provided by NLM:


Further study details as provided by Göteborg University:

Primary Outcome Measures:
  • Weight development [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Eating behaviour (Three Factor Eating Questionnaire) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: August 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
1 week of re-feeding
Behavioral: Re-feeding duration
1 or 6 weeks of re-feeding after VLED-induced weight loss
Other Name: Dietary advice
Experimental: B
6 weeks of re-feeding
Behavioral: Re-feeding duration
1 or 6 weeks of re-feeding after VLED-induced weight loss
Other Name: Dietary advice

Detailed Description:

VLED program:

During the initial 12 weeks, patients were encouraged to follow a strict liquid very-low-energy diet (470-820 kcal). They selected and paid themselves for one of the following commercially available diets; Modifast® (820 kcal), Nutrilett® (560 kcal) or Cambridgekuren® (470 kcal). Free consumption of non-caloric drinks (<6 kcal/100 g) was allowed. All patients had scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. Body weight was registered at each visit and patients were given support and counselling to enhance VLED compliance. Side effects were monitored and a more frequent contact was offered if needed. All patients were encouraged to be physically active.

Dietary treatment:

Following VLED, dietary treatment advice was given during individual dietician counseling at nine study visits (week 12, 15, 18, 21, 26, 32, 38, 44, and 52). At week 12, the dietician assigned patients with ≥10% weight loss to treatment group according to randomization. Standardized written and oral instructions for one or six week re-feeding were provided; hence, participants as well as study staff were aware of group assignment. During re-feeding, ordinary meals were gradually re-introduced and VLED portions removed. Patients with one week re-feeding (Group 1) (instructed at week 12) started with breakfast for three days, added lunch (or dinner) the next four days, and thereafter the third meal was re-introduced and VLED discontinued. Patients with six week re-feeding (Group 6) (instructed at week 12, 15, and 18) started with one regular meal (patient's choice) for three weeks. A second meal was added the next three weeks, and at week eight the third meal was re-introduced and VLED discontinued. For both groups between-meal snacks (e.g. fruit) were recommended from the completion of the re-feeding periods.

Recommended energy intake was based on an estimated energy requirement minus 30% to achieve an energy-reduced level. Energy requirement was calculated from the equation of Harris-Benedict for estimation of basal metabolic rate, adjusted by factor 1.3 for total energy expenditure (moderate level of physical activity). Recommended energy distribution for breakfast, lunch and dinner was 20, 35 and 35% of daily energy intake, and 10% from snacks. Dietary prescriptions followed the Swedish Nutrition Recommendations. All patients were encouraged to increase their level of physical activity.

Power calculation and randomization:

Sample size calculations were based on data from a similar study. A sample size of 75 patients per treatment arm was derived, assuming 80% power to detect a 4 kg weight loss difference, SD 7 kg, statistical significance level P<0.05, and 35% dropout between week 12 and 52.

Two-hundred and sixty-nine patients started on the VLED regimen, and were after 12 weeks eligible for randomization if they had lost ≥10% of initial body weight. The randomization was stratified by the combination of sex and degree of weight loss (strictly greater than or less than 17.1% weight loss). Eligible patients were randomly assigned within each of the four strata to one of the two treatments (one or six weeks re-feeding) in blocks of size two, with equal allocation of treatments within each block. The randomization list was generated with a pseudo-random number generator, so that the resulting treatment sequence was reproducible and unpredictable.

The treatment allocation order was arranged in numbered, sealed envelopes and kept in separate boxes for each strata. At patient assignment, the envelope next in order was drawn from the appropriate strata box.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-60 years
  • BMI > 30 kg/m2
  • speaking swedish

Exclusion Criteria:

  • eating disorder
  • unstable diabetes type 1
  • unstable cardiac disease
  • severe psychiatric disorder
  • pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694811

Locations
Sweden
Sahlgrenska University Hospital
Göteborg, Sweden
Sponsors and Collaborators
Göteborg University
Investigators
Study Chair: Kaj Stenlöf, MD Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
  More Information

No publications provided

Responsible Party: Lena Gripeteg, registered dietician, postgraduate student, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg
ClinicalTrials.gov Identifier: NCT00694811     History of Changes
Other Study ID Numbers: VGFOUREG-1942
Study First Received: June 9, 2008
Last Updated: June 10, 2008
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Göteborg University:
Obesity
Weight loss
Diet
Very-low-energy diet
Predictive factors
Re-feeding

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014