Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
NCT Number: NCT01606813
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.
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Notify Me21 year–70 year
All sexes
Interventional
Not applicable
Hershey, Pennsylvania, 17033, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Physicians and Mid-level providers (Focus group and RCT):
Patients (Focus group only):
Patients (RCT only)
Exclusion criteria
Physicians and Mid-level providers (RCT only)
Patients (Focus group and RCT)
Patients (RCT only)
Standard care
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.
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.
Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.
Time frame: 12 months
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.
Time frame: 12 months
This questionnaire asks participants to estimate how often they consume a variety of specific foods.
Time frame: 12 months
This instrument has been used to estimate leisure time activity in many studies of weight loss (78, 112-113) and changes in energy expenditure using this measure correlate with changes in body weight over at least an 18 month period (114). A scoring algorithm allows the calculation of caloric expenditure overall as well as in activities of light, medium and high intensity.
Time frame: 6 months
After 12 months, data will be collected from medical charts using a standardized form to identify: 1) number of PCP visits, 2) use of any approved (e.g., Xenical) or off-label (e.g., Topiramate) weight loss medications after randomization, and 3) evaluations by a surgical weight control program.
Time frame: 12 months
After the index PCP visit and quarterly, subjects will complete a survey detailing the use the 5 A's (Ask, Advise, Assess, Assist and Arrange) during visits. Within 24-72 hours after the index visit, subjects will be called to complete the exit interview.
Time frame: 12 months
Age, gender, race and ethnicity, smoking status, education and other demographics, will be measured based on standard self-report.
Time frame: 12 months
To measure past weight, past weight loss attempts and methods used to lose weight in the past, we will use the Weight History Questionnaire (WHQ) from the National Health and Nutrition Examination Survey (NHANES).
Time frame: 12 months
To measure health literacy, the Newest Vital Sign (NVS), a nutrition label that is accompanied by 6 questions that requires 3 minutes for administration will be used.
Time frame: 12 months
The TFEQ measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
Time frame: 12 months
Depressive symptoms have been associated with body weight changes, so these symptoms will be measured with the 20-item Centers for Epidemiological Studies Depression Scale (CES-D). *If a patient scores a 25 or higher on the scale, research staff will notify their primary care physician; however, this does not make them ineligible for the study.
Time frame: 12 months
The TSRQ will be used to measure autonomous (5 items) versus controlled (8 items) motivations, as well as total motivation (autonomous + controlled).
Time frame: 12 months
Perceived competence in weight control will be measured using the Efficacy Life-Style Questionnaire (WEL). The WEL is a 20-item instrument consisting of five situational factors (Negative Emotions, Availability, Social Pressure, Physical Discomfort, and Positive Activities).
Time frame: 12 months
Patient satisfaction will be measured with the Patient Satisfaction Questionnaire 18 (PSQ18), which includes scales to measure technical quality, interpersonal manner, communication and time spent with the doctor with scale reliability between 0.79 and 0.93. Accountability will be measured with a 6-item measure developed by Mohr and colleagues (consultant), which measures the extent to which subjects believe that they are being monitored and the extent to which they are concerned about being judged by the monitor.
Time frame: 12 months
This validated questionnaire asks participants about the duration of specific sedentary behaviors during a typical weekday and weekend day.
Time frame: 12 months
This questionnaire asks about participants about their level of confidence in doing physical activity in certain situations.
Time frame: 12 months
The Eating Behavior Inventory (EBI) is a validated questionnaire used by obesity researchers to measure the adoption of specific behaviors linked with weight-loss success.
Time frame: 12 months
This questionnaire asks participants about the frequency of their Internet use and the ways in which they use the Internet
Time frame: 12 months
We will analyze 100% of the personal notes added by PCPs to messages sent to patients in Condition C. Using a grounded theory approach, Dr. Hwang will analyze the content in the notes from PCPs and create a codebook and categories for these notes.
Time frame: 12 months
Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.
Time frame: 12 months
We will examine login data (overall and percentage of weeks logging in) as a mean and median, as well as a monthly percentage.
Time frame: 12 Months
Participants will be asked to bring their current prescription medications. The research coordinator will record the name and dose of each.
Milton S. Hershey Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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