NCT01834859

Brief Summary

Very-low calorie diets are relatively safe and effective in inducing significant weight loss, when used in selective individuals and under clinical supervision. However, weight loss maintenance in the long-term remains the main challenge, with many experiencing a significant weight regain. Several compensatory mechanisms are activated under weight reduction, both at the level of energy intake (such as increased appetite) and energy expenditure (such as reduced energy expenditure), and increase the risk of relapse. The main aim of this study is to compare the effect of two multidisciplinary lifestyle interventions on weight loss maintenance at one year, after initial weight loss during 8 weeks very-low calorie diet. Participants will be allocated (non-randomly) to either an outpatient program in the obesity unit of the local hospital, or to an inpatient program consisting of a "continuous care" intervention, with three intermittent stays (each with three-week duration) in a rehabilitation center over a one year period. Moreover, the investigators aim to assess the impact of weight loss (achieved with a very low calorie diet) and weight loss maintenance on compensatory mechanisms activated during weight reduction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 4, 2020

Status Verified

October 1, 2016

Enrollment Period

3.2 years

First QC Date

April 15, 2013

Last Update Submit

June 2, 2020

Conditions

Obesity, Morbid

Keywords

weight reduction programsdietCaloric restrictionweight lossweight gain

Outcome Measures

Primary Outcomes (1)

  • body weight

    body weight change after end of very-low calory diet

    1 year (changes from baseline to one year)

Secondary Outcomes (9)

  • resting metabolic rate, short-term

    10 weeks

  • appetite, short-term

    10 weeks

  • exercise efficiency, short-term

    10 weeks

  • physical activity level, short-term

    10 weeks

  • resting metabolic rate, long-term

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Outpatient

EXPERIMENTAL

Multidisciplinary outpatient program including both individual and group-based therapy. During the first visit, there will be offered an individual consultation with the dietician, physiotherapist and psychiatric nurse. Follow-up will be in groups meeting every month for the first four months and every two months afterwards up to one year. The intervention will focus on nutritional education, healthy eating, increased physical activity levels (aiming initially at 10 minutes/day, then increasing to 30 minutes/day) and cognitive therapy.

Behavioral: Multidisciplinary outpatient program

Inpatient

EXPERIMENTAL

Inpatient lifestyle program consisting of a "continuous care" weight loss program offered at a rehabilitation center, with three intermittent stays (each with 3-week duration) over a one year period.

Behavioral: Inpatient lifestyle program

Interventions

Multidisciplinary outpatient programBEHAVIORAL

Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)

Outpatient
Inpatient lifestyle programBEHAVIORAL

Diet (phase 1) and lifestyle intervention (phase 2)

Inpatient

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • volunteers from Central Norway
  • if female: taking oral contraceptives or post-menopausal
  • body mass index 30-45 kg/m2
  • stable weight (\<2kg variation in the last 3 months)
  • not currently dieting to lose weight

You may not qualify if:

  • Pregnancy
  • breast feeding
  • drug or alcohol abuse within the last two years
  • current medication known to affect appetite or induce weight loss
  • enrollment in another obesity treatment program
  • history of psychological disorders
  • history of eating disorders
  • history of diabetes type 1 or 2
  • gastrointestinal disorders (particular cholelithiasis)
  • kidney -, liver -, lung- or cardiovascular disease
  • malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

Related Publications (7)

  • Nymo S, Coutinho SR, Jorgensen J, Rehfeld JF, Truby H, Kulseng B, Martins C. Timeline of changes in appetite during weight loss with a ketogenic diet. Int J Obes (Lond). 2017 Aug;41(8):1224-1231. doi: 10.1038/ijo.2017.96. Epub 2017 Apr 25.

    PMID: 28439092RESULT

  • Martins C, Nymo S, Aukan MI, Roekenes JA, Coutinho SR, Hunter GR, Gower BA. Association between ss-Hydroxybutyrate Plasma Concentrations after Hypocaloric Ketogenic Diets and Changes in Body Composition. J Nutr. 2023 Jul;153(7):1944-1949. doi: 10.1016/j.tjnut.2023.05.010. Epub 2023 May 12.

    PMID: 37182692DERIVED

  • Martins C, Nymo S, Coutinho SR, Rehfeld JF, Hunter GR, Gower BA. Association between Fat-Free Mass Loss, Changes in Appetite, and Weight Regain in Individuals with Obesity. J Nutr. 2023 May;153(5):1330-1337. doi: 10.1016/j.tjnut.2023.03.026. Epub 2023 Mar 23.

    PMID: 36963504DERIVED

  • Martins C, Nymo S, Truby H, Rehfeld JF, Hunter GR, Gower BA. Association Between Ketosis and Changes in Appetite Markers with Weight Loss Following a Very Low-Energy Diet. Obesity (Silver Spring). 2020 Dec;28(12):2331-2338. doi: 10.1002/oby.23011.

    PMID: 33230962DERIVED

  • DeBenedictis JN, Nymo S, Ollestad KH, Boyesen GA, Rehfeld JF, Holst JJ, Truby H, Kulseng B, Martins C. Changes in the Homeostatic Appetite System After Weight Loss Reflect a Normalization Toward a Lower Body Weight. J Clin Endocrinol Metab. 2020 Jul 1;105(7):e2538-46. doi: 10.1210/clinem/dgaa202.

    PMID: 32301981DERIVED

  • Lyngstad A, Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Investigating the effect of sex and ketosis on weight-loss-induced changes in appetite. Am J Clin Nutr. 2019 Jun 1;109(6):1511-1518. doi: 10.1093/ajcn/nqz002.

    PMID: 31070711DERIVED

  • Nymo S, Coutinho SR, Rehfeld JF, Truby H, Kulseng B, Martins C. Physiological Predictors of Weight Regain at 1-Year Follow-Up in Weight-Reduced Adults with Obesity. Obesity (Silver Spring). 2019 Jun;27(6):925-931. doi: 10.1002/oby.22476. Epub 2019 Apr 20.

    PMID: 31004405DERIVED

MeSH Terms

Conditions

Obesity, MorbidWeight LossWeight Gain

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Catia Martins, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2013

First Posted

April 18, 2013

Study Start

August 1, 2013

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

June 4, 2020

Record last verified: 2016-10

Locations

NO(1)