Trial Information

Multiple Risk Behavior Intervention in Health Care Settings

HD2 conducted a randomized control trial at two metropolitan Harvard Vanguard Medical
Associates (HVMA) sites. The unit of randomization was the primary care provider.
Providers were randomized to one of three arms:

1. Usual care, a control arm.

2. HD2, an intervention arm, which included access to the study information via website or
study information content via print materials. Content addressed the 5 targeted health
behaviors and goals, the importance of tracking behaviors in order to improve
behaviors, and the importance of social support during behavior change.

3. HD2+, another intervention arm, which included access to the study information content
just described, PLUS two coaching calls.

Note: access to the website was available for the 6 months after recruitment only.

In addition, the investigators wanted to test how use of electronic reminders might increase
engagement with the intervention. So, a sub-set of both intervention arms was randomized to
receive additional electronic reminders. Participants were allowed to choose either AVR
(voicemail) or SMS (text messaging) for the delivery of these brief electronic reminders.

The investigators conducted recruitment on a rolling basis. Patients were assigned to the
conditions to which their primary care providers were randomized. The investigators offered
participation to providers from the Internal Medicine departments who had full patient
panels and conducted annual well visit physicals with adult HVMA patients. All participating
providers were informed about the HD2 study through a presentation by study staff. Providers
could elect to opt out of participation prior to the patient recruitment period.

Potentially eligible patients were sent a recruitment letter before their appointment date.
This letter introduced the study and let patients know that study staff may approach them at
the clinic to further discuss possible participation. The letter also included a phone
number for patients to call if they wanted to opt-out of being approached.

At the appointment, study staff approached people who did not opt out. They discussed the
study, answered any questions, screened for eligibility, and then enrolled interested,
eligible patients. Once patients signed the informed consent they were asked to complete a
written, self-administered, baseline survey and given a small incentive for their time.

After completing the baseline survey, patients in the UC group only received 5 pamphlets
addressing the 5 behaviors of the study. In addition to the study materials described
previously, HD2 and HD2+ participants received a bottle of multi-vitamins and pedometer to
support these two health behaviors. HD2 and HD2+ participants also received a tailored
feedback report based on their baseline survey responses (mailed to participants
approximately one week post recruitment).

All participants who completed the baseline survey were contacted for two follow-up surveys,
which were administered over the phone by survey assistants. The first follow-up survey was
done at the end of their intervention period (6 months post recruitment). The second
follow-up survey was done at 18 months post recruitment). Those participants who were
unreachable by telephone were given the option to complete an abbreviated version of the
survey, which was sent to them via the mail. A small incentive was given to participants
after completion of each follow-up survey.

AIMS:

A.1. To determine the efficacy of the HD2 intervention. Hypothesis 1.1: Participants in
HD2/HD2+ interventions will achieve significantly greater change in the multiple risk
behavior score at 6- and 18-month follow-ups than those UC.

Hypothesis 1.2: Participants in HD2/HD2+ interventions will achieve significantly greater
change in individual risk factors at 6- and 18-month follow-ups, compared to those in UC
(secondary outcomes).

Hypothesis 1.3: Participants who receive electronic reminders will achieve significantly
greater change in the multiple risk behavior score at 6- and 18-month follow-ups than those
who do not.

Hypothesis 1.4: Participants who receive electronic reminders will achieve significantly
greater change in individual risk factors at 6- and 18-month follow-ups than those who do
not.

A.2. To evaluate the impact of the HD2/HD2+ intervention in terms of maximizing
participation/reach, intervention delivery, and cost-effectiveness.

A3. To determine whether providing assistance with a key component of the web site, behavior
tracking, will stimulate higher rates of use.

Validation component of the parent study: N = 150 participants. As part of the protocol,
the investigators recruited a small sample from the original cohort. All quit smokers were
offered enrollment and a random sample of the remaining cohort was offered enrollment. The
investigators used "gold standards" to validate these data. Dietary data (fruit & vegetable,
red meat, multivitamin use) were measured by 24-hour telephone-administered food recall
interviews. Physical activity was measured by accelerometers. Smoking cessation was measured
by saliva cotinine testing.

TRACKING SUBSTUDY (n=100)

Aim of substudy:

To determine whether providing assistance with a key component of the web site, behavior
tracking, will stimulate higher rates of use.

Methods:

All eligible and interested participants will be enrolled recruited into the web arm of the
parent study intervention only. We will use the same eligibility criteria and data
collection.

In summary, self-monitoring rates of enrolled patients will be assessed at day 7 for HD2
website use. If he/she has logged into the HD2 web site and completed behavior tracking at
least 3 times they will continue in the study with no additional technical support.
Participants who have not completed behavior self-monitoring at least 3 times will then be
divided into two groups. Group 1 will receive Automated Assistance (emails) only and Group 2
will receive Personal Assistance (2 calls from trained staff offering technical assistance
if needed) & Automated Assistance emails like Group 1.