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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00694811
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : June 11, 2008
Sponsor:
Information provided by:
Göteborg University

Tracking Information
First Submitted Date  ICMJE June 9, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date June 11, 2008
Study Start Date  ICMJE August 2004
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Weight development [ Time Frame: 52 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2008)
Eating behaviour (Three Factor Eating Questionnaire) [ Time Frame: 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Re-Feeding Duration on Weight Maintenance After Weight Loss With Very-Low-Energy Diets (VLEDs)
Official Title  ICMJE 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
Brief Summary 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE Behavioral: Re-feeding duration
1 or 6 weeks of re-feeding after VLED-induced weight loss
Other Name: Dietary advice
Study Arms  ICMJE
  • Experimental: A
    1 week of re-feeding
    Intervention: Behavioral: Re-feeding duration
  • Experimental: B
    6 weeks of re-feeding
    Intervention: Behavioral: Re-feeding duration
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 10, 2008)
169
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00694811
Other Study ID Numbers  ICMJE VGFOUREG-1942
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lena Gripeteg, registered dietician, postgraduate student, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg
Study Sponsor  ICMJE Göteborg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kaj Stenlöf, MD Institute of Medicine, Sahlgrenska Academy, University of Gothenburg
PRS Account Göteborg University
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP