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

NCT ID: NCT01606813

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 611 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-11-30

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.

Conditions

Overweight; Obese

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief physician counseling (BPC) + Usual care (UC)

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.

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: OTHER

Standard care

Brief Physician Counseling

Intervention Type: BEHAVIORAL

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.

BPC + Internet Weight Control Program (IWCP)

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.

Group Type: EXPERIMENTAL

Brief Physician Counseling

Intervention Type: BEHAVIORAL

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.

Referral and access to an internet weight control program

Intervention Type: BEHAVIORAL

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.

BPC + IWCP + Follow up email notes from PCP

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).

Group Type: EXPERIMENTAL

Brief Physician Counseling

Intervention Type: BEHAVIORAL

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.

Referral and access to an internet weight control program

Intervention Type: BEHAVIORAL

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.

Brief follow up email notes from PCPs

Intervention Type: BEHAVIORAL

Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.

Interventions

Usual Care

Standard care

Intervention Type: OTHER

Brief Physician Counseling

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.

Intervention Type: BEHAVIORAL

Referral and access to an internet weight control program

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.

Intervention Type: BEHAVIORAL

Brief follow up email notes from PCPs

Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Christopher Sciamanna, MD, MPH

Professor; Division Chief of General Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher Sciamanna, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

1R01DK095078-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

39237EP

Identifier Type: -

Identifier Source: org_study_id