Overview

This trial is active, not recruiting.

Conditions overweight, obese
Treatments usual care, brief physician counseling, referral and access to an internet weight control program, brief follow up email notes from pcps
Sponsor Milton S. Hershey Medical Center
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2012
End date November 2016
Trial size 611 participants
Trial identifier NCT01606813, 1R01DK095078-01, 39237EP

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model factorial assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(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.
usual care
Standard care
brief physician counseling
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.
(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.
brief physician counseling
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.
referral and access to an internet weight control program
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.
(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).
brief physician counseling
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.
referral and access to an internet weight control program
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.
brief follow up email notes from pcps
Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.

Primary Outcomes

Measure
Body Weight
time frame: 12 months

Secondary Outcomes

Measure
Block Food Frequency Questionnaire
time frame: 12 months
Paffenbarger Activity Questionnaire
time frame: 12 months
Patterns of medical care
time frame: 6 months
Use of the 5 A's during PCP Visits
time frame: 12 months
Sociodemographics and tobacco use
time frame: 12 months
Weight History Questionnaire
time frame: 12 months
Health Literacy
time frame: 12 months
Three-Factor Eating Questionnaire (TFEQ)
time frame: 12 months
Depressive Symptoms
time frame: 12 months
Treatment Self-Regulation Scale (TSRQ)
time frame: 12 months
Weight Control Self-Efficacy
time frame: 12 months
Patient Satisfaction and Accountability
time frame: 12 months
Sedentary Behavior
time frame: 12 months
Physical Activity Self Efficacy
time frame: 12 months
Eating Behavior Inventory
time frame: 12 months
Internet Usage
time frame: 12 months
Analysis of text edits in PCP emails
time frame: 12 months
Blood pressure
time frame: 12 months
Adherence (logins to website)
time frame: 12 months
Medication
time frame: 12 Months

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

INCLUSION CRITERIA: 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 - Body Mass Index between 25.0-50.0 kg/m2 - Have internet access at home or work - Patient of a PCP who is participating in the study - Patient has been seeing the PCP for at least 12 months and has no other PCP - The PCP must approve the patients' participation EXCLUSION CRITERIA: 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 - Participating in an online or community weight loss program (e.g., Weight Watchers) and not willing to stop for the duration of the study - Doctor has diagnosed a heart condition and said should only do physical activity recommended by doctor - Feel pain in chest when doing physical activity - In the past month, have had chest pain when not doing physical activity - In the end stages of renal, liver or kidney diseases - Has heart failure - Has/had cancer in past 5 years (except non-melanoma skin cancer) - Cannot walk for exercise for 10 minutes - Not willing to participate in 12-month intervention - Taking insulin - Treated for or diagnosed with an eating disorder - Diagnosed with HIV - Two weeks of steroid use in past year

Additional Information

Official title The Impact of Integrating an Internet Weight Control Program Into Primary Care
Principal investigator Christopher Sciamanna, MD, MPH
Description Every year, roughly 700 of the 750 million visits that overweight and obese patients make with primary care providers (PCPs) occur without any weight counseling. The main reasons for this are that PCPs are poorly trained to help their patients lose weight and that there are no consistently effective interventions for primary care settings. Though in-person and telephone-based weight control programs have been difficult to disseminate in primary care, online weight control programs are increasingly effective and may lend themselves to be used in these settings. Given the growing number of effective online programs, for obesity and for other conditions seen in primary care (e.g., depression, insomnia) it is important to understand whether these programs can be effective when integrated into primary care and whether they are enhanced by provider involvement. Research on the 5 A's model of primary care behavior change suggests that the most effective, yet least used feature of primary care interventions is arranging follow-up, where providers hold patients accountable to adhering to treatments and achieving specific outcomes. The 5 A's model provides a useful framework for integrating behavior change interventions into primary care. In this model, providers ASK about weight, ADVISE patients to lose weight, ASSESS readiness to change, ASSIST the patient in making changes and ARRANGE follow-up. Unfortunately, though PCPs are uniquely positioned to ARRANGE follow-up, given their long-term relationship with the patient, and studies show that ARRANGING follow-up may be the most effective of the 5 A's, it is the least often used. In a study of 481 encounters with overweight patients, Pollak (Consultant) and colleagues observed that PCPs ARRANGED follow-up in only 5% of visits, though it was the only one of the 5 A's associated with future weight loss. Kottke and colleagues similarly observed that primary care smoking cessation interventions that included more "reinforcing sessions" with PCPs were the most effective. This is consistent with conclusions by Whitlock and colleagues that "Simply notifying patients that follow-up will occur seems to be a powerful motivating factor". These findings have been extended to online interventions, where two meta-analyses concluded that the impact of online interventions for depression and anxiety is enhanced by follow-up that includes being accountable to and supported by a human being. The investigators have created a simple method for integrating an Internet weight control program into primary care settings, by allowing PCPs to monitor their patients' adherence and outcomes and email them pre-written, tailored follow-up messages. PCPs in the investigators' pilot work believed that this would help to overcome key barriers to helping their patients lose weight.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.