NCT01920620

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
176

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable obesity

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

4.6 years

First QC Date

August 8, 2013

Last Update Submit

January 19, 2016

Conditions

Obesity

Keywords

obesity, inpatient, intervention, weight loss

Outcome Measures

Primary Outcomes (1)

  • Weight loss between groups

    6 months

Secondary Outcomes (3)

  • Weight loss from baseline

    6 months

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores

    6 months

  • Change in waist-to-hip ratios

    6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Inpatient weight loss counseling Motivational interviewing and troubleshooting via phone

Behavioral: Inpatient weight loss counselingBehavioral: Motivational interviewing and troubleshooting via phone

Usual Care Arm

NO INTERVENTION

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.

Interventions

Inpatient weight loss counselingBEHAVIORAL

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.

Intervention Arm
Motivational interviewing and troubleshooting via phoneBEHAVIORAL

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.

Intervention Arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

ObesityWeight Loss

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Kelley N Wachsberg, M.D., M.S.

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 8, 2013

First Posted

August 12, 2013

Study Start

January 1, 2011

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

US(1)