Overweight Clinical Trial
Official title:
The Impact of Integrating an Internet Weight Control Program Into Primary Care
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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