Inpatient Obesity Intervention With Phone Follow-up

January 19, 2016 updated by: Kelley Wachsberg, Northwestern University

Inpatient Obesity: Can Weight Loss Intervention During Hospitalization Lead to Sustained Weight Loss at Six Months Following Discharge?

In this study we sought to determine whether inpatient weight loss counseling with post discharge phone follow-up would result in weight loss at six months. Secondary endpoints included weight change from baseline, changes in waist-to-hip ratios, assessment of weight perceptions and changes in patient reported health outcome measures. To our knowledge, this is the first randomized trial designed to evaluate the effects of an obesity intervention with post-discharge follow-up in an inpatient general medicine population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults ages 18-65 years old
  • Body mass index between 30-50 kg/m2
  • Admitted to an internal medicine service

Exclusion Criteria:

  • acute medical conditions known to affect weight (heart failure, cirrhosis, end-stage renal disease on dialysis, nephrotic syndrome, or pregnancy)
  • Charlson comorbidity index >3
  • moderate to severe major depression
  • prolonged steroid use (>2 weeks)
  • initiation of medications known to affect weight
  • non-English speaking
  • precontemplation stage of change

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Inpatient weight loss counseling Motivational interviewing and troubleshooting via phone
Behavioral: Inpatient weight loss counseling
Weight loss counseling utilizing a 13 minute patient education video on weight loss and an 25 minute personalized health education session. Subjects set 3 specific behavior set three specific lifestyle goals prior to discharge including a calculated six month weight loss goal (10% of body weight) and specific dietary and fitness goals. Usual care group participants received no specific instruction regarding weight loss prior to discharge.
Behavioral: Motivational interviewing and troubleshooting via phone
All subjects were asked to track their weights over the 6 month duration of the study. Weights were obtained by phone at weeks 1,2,3,4, 8, 12, 16, 20 and 24. Phone calls for the intervention group utilized motivational and troubleshooting techniques whereas calls in the usual care group were used only to obtain weight and assess for changes in medications or health condition.
No Intervention: Usual Care Arm
Participants in the usual care group were not provided with any specific instructions regarding weight loss, diet or exercise prior to discharge. Follow-up phone calls for usual care subject were used only to obtain weight and assess for changes in medications or health condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight loss between groups
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight loss from baseline
Time Frame: 6 months
6 months
Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores
Time Frame: 6 months
6 months
Change in waist-to-hip ratios
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Kelley N Wachsberg, M.D., M.S., Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 8, 2013

First Posted (Estimate)

August 12, 2013

Study Record Updates

Last Update Posted (Estimate)

January 20, 2016

Last Update Submitted That Met QC Criteria

January 19, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity Intervention NU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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