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

• ClinicalTrials.gov Identifier: NCT00694811
• Recruitment Status: Completed
• First Posted: June 11, 2008
• Last Update Posted: June 11, 2008
• Sponsor: Göteborg University
• Information provided by: Göteborg University

Tracking Information

• First Submitted Date: June 9, 2008
• First Posted Date: June 11, 2008
• Last Update Posted Date: June 11, 2008
• Study Start Date: August 2004
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 10, 2008): Weight development [ Time Frame: 52 weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: June 10, 2008): Eating behaviour (Three Factor Eating Questionnaire) [ Time Frame: 52 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Re-Feeding Duration on Weight Maintenance After Weight Loss With Very-Low-Energy Diets (VLEDs)
• 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
• 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

Behavioral: Re-feeding duration

1 or 6 weeks of re-feeding after VLED-induced weight loss

Other Name: Dietary advice

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 10, 2008): 169
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2008
• Actual Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00694811
• Other Study ID Numbers: VGFOUREG-1942
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Lena Gripeteg, registered dietician, postgraduate student, Sahlgrenska University Hospital, Sahlgrenska Academy, University of Gothenburg
• Study Sponsor: Göteborg University
• Collaborators: Not Provided

Investigators

• Study Chair: Kaj Stenlöf, MD; Institute of Medicine, Sahlgrenska Academy, University of Gothenburg

• PRS Account: Göteborg University
• Verification Date: June 2008