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Completed

NCT Number: NCT01920620

Inpatient Obesity Intervention With Phone Follow-up

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inpatient weight loss counseling

Behavioral

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.

Motivational interviewing and troubleshooting via phone

Behavioral

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.

Primary outcomes

  1. Weight loss between groups

    Time frame: 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2013
Registry last updated
Jan 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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