The Impact of Integrating an Internet Weight Control Program Into Primary Care

NCT01606813 | Completed DMC

• 2 other identifiers: 39237EP1R01DK095078-01
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will conduct a randomized controlled trial comparing the effects of three interventions on weight loss at 12 months. The investigators propose to test the impact of integrating an effective automated Internet weight control program into primary care by recruiting patients and randomizing them to one of three conditions: A) Brief physician counseling plus usual care, B) Brief physician counseling plus referral and access to the Internet weight control program and, C) Brief physician counseling plus referral and access to the Internet weight control program plus brief follow-up email notes of support and accountability from Primary Care Physicians. The investigators hypothesize that an online program for weight control can be more effective by enhancing online follow-up with PCPs.

Conditions

Overweight; Obese

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Body weight and height will be measured by a research assistant using a portable, calibrated stadiometer (Tanita, Inc). Waist circumference will be measured using standard procedures, recorded to the nearest millimeter.

  12 months

Secondary Outcomes (20)

• Block Food Frequency Questionnaire

  12 months

• Paffenbarger Activity Questionnaire

  12 months

• Patterns of medical care

  6 months

• Use of the 5 A's during PCP Visits

  12 months

• Sociodemographics and tobacco use

  12 months

Study Arms (3)

Brief physician counseling (BPC) + Usual care (UC)

ACTIVE COMPARATOR

The participant will receive standard care. They will receive BPC from their PCP on weight loss by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss.

Other: Usual Care; Behavioral: Brief Physician Counseling

BPC + Internet Weight Control Program (IWCP)

EXPERIMENTAL

The participant will receive BPC from their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program.

Behavioral: Brief Physician Counseling; Behavioral: Referral and access to an internet weight control program

BPC + IWCP + Follow up email notes from PCP

EXPERIMENTAL

The participant will receive BPC form their PCP by reviewing a goal setting worksheet and collaboratively setting a goal for weight loss. They will receive referral and access to an internet weight control program. And they will receive brief follow up email notes from PCPs on how their weight loss is going (from data collected from the weight loss website).

Behavioral: Brief Physician Counseling; Behavioral: Referral and access to an internet weight control program; Behavioral: Brief follow up email notes from PCPs

Interventions

Usual Care OTHER

Standard care

Brief physician counseling (BPC) + Usual care (UC)

Brief Physician Counseling BEHAVIORAL

Primary Care Physician (PCP) will review a goal setting worksheet for weight loss with the participant and then collaboratively set a goal for weight loss.

BPC + IWCP + Follow up email notes from PCP; BPC + Internet Weight Control Program (IWCP); Brief physician counseling (BPC) + Usual care (UC)

Referral and access to an internet weight control program BEHAVIORAL

Participants will receive a login and password for the weight loss website. The website will encourage patients to set a new weight goal every 3 months and work towards a total weight loss goal of 10%. Patients will also receive an email prompt each week alerting them to new content and reminding them to check-in to the website to report their weight, intake and activity.

BPC + IWCP + Follow up email notes from PCP; BPC + Internet Weight Control Program (IWCP)

Brief follow up email notes from PCPs BEHAVIORAL

Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.

BPC + IWCP + Follow up email notes from PCP

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physicians and Mid-level providers (Focus group and RCT):
• Has medical license to practice primary care
• Practice within 60 miles (focus group)/100 miles (RCT) of Penn State Hershey Medical Center
• Practice not located at Penn State Hershey Medical Center campus (focus group)
• Be active primary care providers (provide primary care at least 2 half days per week at one practice)
• Not have had completed a weight management fellowship
• Use internet in their office
• Patients (Focus group only):
• Ages 21-60
• Body Mass Index between 25.0-50.0 kg/m2
• Have internet access at home or work
• Patient of a primary care provider who practices Internal Medicine or Family Community Medicine
• Has seen primary care provider in the last year, not including acute care
• Patients (RCT only)
• Ages 21-70

You may not qualify if:

• Physicians and Mid-level providers (RCT only)
• Practice serves a specialty care population
• Pregnant or planning to become pregnant in the next 3 months
• Planning on changing practice locations in the next 12 months
• Planning on retiring in the next 12 months
• Patients (Focus group and RCT)
• Losing \>5% of current body weight in the previous 6 months
• Participating in a research project involving weight loss or physical activity in the previous 6 months
• Pregnancy during the previous 6 months, lactating, or planning to become pregnant in the next 3 months (focus group)/12 months (RCT)
• Planning on moving out of the area in the next 3 months (focus group)/12 months (RCT)
• Current treatment for a condition or with a medication that could impact weight (Orlistat - aka. Alli, Phentermine, Topiramate - aka. Topamax) and are not willing to stop for duration of the study
• Hospitalization for psychiatric problems during the prior year
• Patients (RCT only)
• Had weight loss surgery
• Planning on changing primary care provider in the next 12 months

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• University of North Carolina, Chapel Hill: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Christopher Sciamanna, MD, MPH

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Division Chief of General Internal Medicine

Study Record Dates

• First Submitted: May 24, 2012
• First Posted: May 28, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)