Clinical trial NCT01606813: The Impact of Integrating an Internet Weight Control Program Into Primary Care
Official title: The Impact of Integrating an Internet Weight Control Program Into Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obese
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: University of North Carolina, Chapel Hill
name: The University of Texas Health Science Center, Houston
First posted: 2012-05-28
Enrollment: 611
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Body Weight
timeFrame: 12 months
Secondary outcomes:
measure: Block Food Frequency Questionnaire
timeFrame: 12 months
measure: Paffenbarger Activity Questionnaire
timeFrame: 12 months
measure: Patterns of medical care
timeFrame: 6 months
measure: Use of the 5 A's during PCP Visits
timeFrame: 12 months
measure: Sociodemographics and tobacco use
timeFrame: 12 months
measure: Weight History Questionnaire
timeFrame: 12 months
measure: Health Literacy
timeFrame: 12 months
measure: Three-Factor Eating Questionnaire (TFEQ)
timeFrame: 12 months
measure: Depressive Symptoms
timeFrame: 12 months
measure: Treatment Self-Regulation Scale (TSRQ)
timeFrame: 12 months
measure: Weight Control Self-Efficacy
timeFrame: 12 months
measure: Patient Satisfaction and Accountability
timeFrame: 12 months
measure: Sedentary Behavior
timeFrame: 12 months
measure: Physical Activity Self Efficacy
timeFrame: 12 months
measure: Eating Behavior Inventory
timeFrame: 12 months
measure: Internet Usage
timeFrame: 12 months
measure: Analysis of text edits in PCP emails
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Adherence (logins to website)
timeFrame: 12 months
measure: Medication
timeFrame: 12 Months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Christopher Sciamanna, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: