NCT02341001

Brief Summary

The purpose of this study is to determine whether text message support after discharge from a bariatric service improves outcomes following bariatric surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jan 2015

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

November 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

November 24, 2014

Last Update Submit

October 26, 2017

Conditions

Keywords

Bariatric surgerySleeve gastrectomyText messagingWeight lossBAROSFollow-up care

Outcome Measures

Primary Outcomes (1)

  • Percent of excess weight lost

    Twelve months

Secondary Outcomes (1)

  • Bariatric Analysis and Reporting Outcome System (BAROS)

    Twelve months

Other Outcomes (2)

  • Number of re-referrals to the bariatric clinic

    Twelve months

  • Cost comparison

    Twelve months

Study Arms (2)

Standard care

NO INTERVENTION

Patients are discharged from the bariatric service at 18 months after surgery.

Standard care with text message support

EXPERIMENTAL

Patients are discharged from the bariatric service at 18 months after surgery but receive a daily text message for one year.

Other: Daily text message of support

Interventions

Standard care with text message support

Eligibility Criteria

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

You may qualify if:

  • All patients who have had a sleeve gastrectomy 18 months ago and are attending the discharge follow-up appointment

You may not qualify if:

  • Patients who do not have the ability to receive text messages
  • Patients who do not understand written English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Counties Manukau District Health Board

Auckland, New Zealand

Location

Related Publications (1)

  • Lauti M, Kularatna M, Pillai A, Hill AG, MacCormick AD. A Randomised Trial of Text Message Support for Reducing Weight Regain Following Sleeve Gastrectomy. Obes Surg. 2018 Aug;28(8):2178-2186. doi: 10.1007/s11695-018-3176-1.

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

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

Study Officials

  • Andrew D MacCormick, MBChB, PhD

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR
  • Melanie Lauti, MBChB

    University of Auckland, New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

November 24, 2014

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations