NCT03246672

Brief Summary

Although bariatric surgery is highly effective for inducing significant weight loss and resolution of comorbidities, weight regain following surgery is a common problem. This pilot study will test the feasibility and acceptability of an intervention designed to help bariatric surgery patients maintain weight loss. Findings from this pilot will provide the foundation for a randomized controlled trial to evaluate the efficacy of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Shorter than P25 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

August 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

August 19, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

August 7, 2017

Results QC Date

April 17, 2019

Last Update Submit

July 15, 2019

Conditions

Obesity, Morbid

Keywords

obesity, morbid

Outcome Measures

Primary Outcomes (2)

  • Recruitment Rate

    Percentage of contacted patients who consent to be in the study

    week 0

  • Retention Rate

    Percentage of patients with baseline data who complete 16-week outcome assessments

    16-week outcome assessment

Secondary Outcomes (1)

  • Weight

    16 weeks

Study Arms (1)

maintenance

EXPERIMENTAL

behavioral intervention to increase adherence to lifestyle recommendations

Behavioral: maintenance intervention

Interventions

maintenance interventionBEHAVIORAL

Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.

maintenance

Eligibility Criteria

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

You may qualify if:

  • Bariatric surgery at a participating VA site
  • Laparoscopic Roux-en-Y gastric bypass (RYGB) or laparoscopic vertical sleeve gastrectomy (SG) six to 18 months prior to the time of data pull
  • English as preferred language
  • Regular access to a telephone

You may not qualify if:

  • Receipt of procedure to prevent gastric cancer
  • Revisional bariatric surgery
  • Hearing impairment
  • Cancer not in remission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

  • Adamek KE, Ramadurai D, Gunzburger E, Plomondon ME, Ho PM, Raghavan S. Association of Diabetes Mellitus Status and Glycemic Control With Secondary Prevention Medication Adherence After Acute Myocardial Infarction. J Am Heart Assoc. 2019 Feb 5;8(3):e011448. doi: 10.1161/JAHA.118.011448.

    PMID: 30712488RESULT

  • Voils CI, Adler R, Strawbridge E, Grubber J, Allen KD, Olsen MK, McVay MA, Raghavan S, Raffa SD, Funk LM. Early-phase study of a telephone-based intervention to reduce weight regain among bariatric surgery patients. Health Psychol. 2020 May;39(5):391-402. doi: 10.1037/hea0000835. Epub 2020 Jan 30.

    PMID: 31999175DERIVED

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Corrine Voils
Organization
William S Middleton Memorial Veterans Hospital
corrine.voils@va.gov
608-262-9636

Study Officials

  • Corrine I. Voils, PhD

    William S. Middleton Memorial Veterans Hospital, Madison, WI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants receive the intervention
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 11, 2017

Study Start

January 3, 2018

Primary Completion

June 22, 2018

Study Completion

July 31, 2018

Last Updated

August 19, 2019

Results First Posted

August 19, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)