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Inpatient Obesity Intervention With Phone Follow-up

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ClinicalTrials.gov Identifier: NCT01920620
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : January 20, 2016
Sponsor:
Information provided by (Responsible Party):
Kelley Wachsberg, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Inpatient weight loss counseling Behavioral: Motivational interviewing and troubleshooting via phone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Inpatient Obesity: Can Weight Loss Intervention During Hospitalization Lead to Sustained Weight Loss at Six Months Following Discharge?
Study Start Date : January 2011
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Weight loss between groups [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Weight loss from baseline [ Time Frame: 6 months ]
  2. Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores [ Time Frame: 6 months ]
  3. Change in waist-to-hip ratios [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920620


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Kelley N Wachsberg, M.D., M.S. Northwestern University

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Responsible Party: Kelley Wachsberg, Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01920620     History of Changes
Other Study ID Numbers: Obesity Intervention NU
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016

Keywords provided by Kelley Wachsberg, Northwestern University:
obesity, inpatient, intervention, weight loss

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms