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



Status:Active, not recruiting
Conditions:Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:21 - 70
Updated:7/2/2016
Start Date:October 2012
End Date:April 2017

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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.

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.

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
We found this trial at
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Hershey, Pennsylvania 17033
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