The Impact of Integrating an Internet Weight Control Program Into Primary Care
- Conditions
- ObeseOverweight
- Interventions
- Behavioral: Brief Physician CounselingOther: Usual CareBehavioral: Referral and access to an internet weight control programBehavioral: Brief follow up email notes from PCPs
- Registration Number
- NCT01606813
- Lead Sponsor
- Milton S. Hershey Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description BPC + Internet Weight Control Program (IWCP) Brief Physician Counseling 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 (BPC) + Usual care (UC) Brief Physician Counseling 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. BPC + IWCP + Follow up email notes from PCP Brief follow up email notes from PCPs 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 (BPC) + Usual care (UC) Usual Care 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. BPC + Internet Weight Control Program (IWCP) Referral and access to an internet weight control program 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. BPC + IWCP + Follow up email notes from PCP Brief Physician Counseling 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). BPC + IWCP + Follow up email notes from PCP Referral and access to an internet weight control program 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).
- Primary Outcome Measures
Name Time Method Body Weight 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.
- Secondary Outcome Measures
Name Time Method Use of the 5 A's during PCP Visits 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.
Health Literacy 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.
Three-Factor Eating Questionnaire (TFEQ) 12 months The TFEQ measures three dimensions of dietary restraint: cognitive restraint, disinhibition, perceived hunger.
Depressive Symptoms 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.
Block Food Frequency Questionnaire 12 months This questionnaire asks participants to estimate how often they consume a variety of specific foods.
Sociodemographics and tobacco use 12 months Age, gender, race and ethnicity, smoking status, education and other demographics, will be measured based on standard self-report.
Patient Satisfaction and Accountability 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.
Sedentary Behavior 12 months This validated questionnaire asks participants about the duration of specific sedentary behaviors during a typical weekday and weekend day.
Medication 12 Months Participants will be asked to bring their current prescription medications. The research coordinator will record the name and dose of each.
Internet Usage 12 months This questionnaire asks participants about the frequency of their Internet use and the ways in which they use the Internet
Weight History Questionnaire 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).
Patterns of medical care 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.
Treatment Self-Regulation Scale (TSRQ) 12 months The TSRQ will be used to measure autonomous (5 items) versus controlled (8 items) motivations, as well as total motivation (autonomous + controlled).
Physical Activity Self Efficacy 12 months This questionnaire asks about participants about their level of confidence in doing physical activity in certain situations.
Eating Behavior Inventory 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.
Paffenbarger Activity Questionnaire 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.
Analysis of text edits in PCP emails 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.
Weight Control Self-Efficacy 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).
Blood pressure 12 months Blood pressure will be measured by a research assistant using an automatic blood pressure monitor (Omron) and standard procedures.
Adherence (logins to website) 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.
Trial Locations
- Locations (1)
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States