Inpatient Obesity Intervention With Phone Follow-up

Overview

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.

Full Title of Study: “Inpatient Obesity: Can Weight Loss Intervention During Hospitalization Lead to Sustained Weight Loss at Six Months Following Discharge?”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Intervention Arm
    • Inpatient weight loss counseling Motivational interviewing and troubleshooting via phone
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Weight loss between groups
    • Time Frame: 6 months

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kelley Wachsberg, Assistant Professor – Northwestern University
  • Overall Official(s)
    • Kelley N Wachsberg, M.D., M.S., Principal Investigator, Northwestern University

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