NCT02885220

Brief Summary

The aim of our study is to determine if the goal directed weight loss program improves weight loss versus the conventional weight loss program after laparoscopic sleeve gastrectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 31, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

6.9 years

First QC Date

June 21, 2016

Last Update Submit

April 7, 2022

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Mean excess weight loss

    12 months

Secondary Outcomes (3)

  • Quality of life (SF36 questionaire)

    12 months

  • Complications and adverse events

    12 months

  • Remission of co-morbidities

    12 months

Study Arms (2)

Conventional Program

ACTIVE COMPARATOR

The aim of our study is to determine if a goal directed program improves weight loss outcomes after sleeve gastrectomy. In the conventional weight loss program, patients will only be given their ideal weight to strive toward after surgery. Routine dietary and physiotherapy/exercise counseling are provided and patients would be educated on their ideal weights based on a BMI of 23. The target weight loss over a 12 month period would be 100% excess weight loss.

Other: Conventional Program

Goal Directed Program

EXPERIMENTAL

For the goal directed program, patients would be given an additional sheet to show expected weight loss goals to strive towards at each consultation after surgery (3, 6, 9 and 12 months post operation). Bariatric patients in this modified program will be counselled prior to laparoscopic sleeve gastrectomy (LSG) and EWL (excess weight loss) targets will be set for patients to achieve at fixed intervals post LSG. These targets are charted in a graph, with the patient's actual weight charted on the graph at each clinic consultation, providing a strong visual aid counselling and motivation.

Other: Goal-directed Program

Interventions

Conventional ProgramOTHER

No scheduled intermediate weight loss goals provided to patient

Conventional Program
Goal-directed ProgramOTHER

Scheduled program with intermediate weight loss targets reinforced to patients during follow up.

Goal Directed Program

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having met the indications for laparoscopic sleevel gastrectomy, determined preoperatively by the attending surgeon
  • Age \>21 or \<65
  • BMI \>32.5 and \<45
  • Mentally Sound
  • Agreeable to commit to the length of follow up
  • Agreeable for randomization and signed consent form

You may not qualify if:

  • No signed consent form
  • Age \<21 or \>65
  • BMI \<32.5 or \>45
  • Previous Bariatric surgery
  • Mentally Unsound
  • Unable to commit to follow up schedule
  • Pregnant women or women who are breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, 119228, Singapore

Location

Related Publications (4)

  • Locke, E. A. (1996). Motivation through conscious goal setting. Applied and Preventive Psychology, 5(2), 117-124.

    BACKGROUND

  • Wing, R. R. (2002). Behavioral weight control. Handbook of obesity treatment, 2, 301-317.

    BACKGROUND

  • Wadden TA, Foster GD. Behavioral treatment of obesity. Med Clin North Am. 2000 Mar;84(2):441-61, vii. doi: 10.1016/s0025-7125(05)70230-3.

    PMID: 10793651BACKGROUND

  • Kim G, Tan CS, Ng JY, Cheng AKS, Rao J, Soe KT, Kong LW, Naseer F, Er PSY, Lomanto D, So JBY, Shabbir A. Goal-directed program after sleeve gastrectomy improves weight loss. Surg Obes Relat Dis. 2016 Mar-Apr;12(3):518-521. doi: 10.1016/j.soard.2015.11.014. Epub 2015 Nov 19.

    PMID: 26944549BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

June 21, 2016

First Posted

August 31, 2016

Study Start

October 1, 2015

Primary Completion

September 1, 2022

Study Completion

April 1, 2023

Last Updated

April 14, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)