By David Kiefer, MD, Editor

Clinical Assistant Professor, Department of Family Medicine, University of Wisconsin; Clinical Assistant Professor of Medicine, Arizona Center for Integrative Medicine, University of Arizona, Tucson

Dr. Kiefer reports no financial relationships relevant to this field of study.

SUMMARY POINTS

  • In this study, 105 women with a history of breast cancer were randomized to exercise and dietary intervention (either administered via phone or internet) or usual care for 12 months.
  • Women in the intervention groups exercised more (moderate intensity only) than the usual care group, but weight loss was less only at the six-month mark (by 12 months weight changes were the same in all groups).

SYNOPSIS: A web- and phone-based intervention led to significant weight loss and a modest increase in moderate-to-vigorous activity in women at risk of breast cancer.

SOURCE: Cadmus-Bertram L, Nelson SH, Hartman S, et al. Randomized trial of a phone- and web-based weight loss program for women at elevated breast cancer risk: The HELP study. J Behav Med 2016;39:551-559.

What classifies as an integrative health intervention? Lifestyle recommendations are surely a part of what every practicing clinician brings to a patient encounter, although perhaps it is emphasized more in some fields than others. A key part of a healthy lifestyle is increasing activity, or exercise, levels as much as possible; the data support this for a variety of diagnoses and conditions. With the rise of technology, many eHealth interventions can serve as useful adjuncts to patients’ efforts at behavior change. This clinical trial was an offshoot of pilot work showing that telephone-based coaching, web-based logs, and the use of an accelerometer (in this case the ActiGraph accelerometer, to count steps) to measure physical activity can lead to important changes in physical activity and weight loss.

In this way, Cadmus-Bertram sought a unique solution to modifying two important risk factors for breast cancer: physical inactivity and obesity. They identified women in San Diego at risk for breast cancer: women with a prior history of carcinoma in situ or a Gail model score of 1.7 or higher (or a 1.7% five-year risk of breast cancer, factoring in several variables). Women were excluded if they already exercised 150 minutes (moderate intensity) weekly, did not have access to high-speed internet, or did not speak fluent English.

Study participants were randomized to either phone- and web-based intervention or usual care for 12 months. There were several activity and weight loss goals in the intervention group. (See Table 1.)

Table 1: Physical Activity and Weight Loss Goals in the Intervention Group

  • 150 minutes of moderate-to-vigorous physical activity per week
  • Calorie restriction to achieve 1 to 2 pound weight loss weekly (500 kcal per day less ingestion)
  • First 3 to 6 months: 10% weight loss
  • Remaining 6 to 9 months: maintenance

Over the year, the study participants had 18 phone calls (30 minutes each) with trained lay health coaches. The coach did not change over the course of the study, providing some continuity, and the sessions were spaced over the 12 months with decreasing frequency. Topics ranged from sleep and stress management, to exercise and dietary choices. These were reinforced in a written manual that each participant received. Furthermore, the website Sparkpeople.com was used to log activity levels and food intake, and help study participants with motivation, provide feedback about dietary choices, and share useful ideas relevant to their behavior change.

People in the usual care group were given a copy of the U.S. Dietary Guidelines for Americans, and received four 15-minute phone calls (one every three months). This call was merely to check in, ensure continued participation in the study, and ask whether the participant had reviewed the guidelines and which part(s) they found most useful. No directed coaching was administered.

With respect to measurement, height, weight, and number of steps as per the accelerometer were noted. The outcome variable was the total activity (accelerometer) at 12 months, and the independent variable was the percent weight loss. Of note, the accelerometer was only worn at baseline prior to randomization and 12 months; at each of these time points, the accelerometer was worn during waking hours for seven consecutive days.

A total of 105 women were included in the randomization, 71 for the intervention group and 34 for usual care. At the end of 12 months, 59/71 remained for the intervention group, and 29/34 remained for the usual care group. The average age was 60.3 years, the average Gail Model score was 2.6, and the average body mass index (BMI) was 32.1 kg/m2. Results for weight gain and physical activity are shown in Table 2. The intervention group lost more weight than the usual care group at six months, but by 12 months, the usual care group’s weight loss had caught up to the point of being similar to the intervention group’s weight loss. For exercise, an increase of 12 minutes daily of moderate-to-vigorous physical activity was seen in the intervention group, but not in usual care. Interestingly, overall physical exercise, which includes light-intensity exercise, decreased in both groups, although less so in the intervention group: 13 minutes/day (intervention) vs. 61 minutes per day (usual care group) (P = 0.03).

Table 2: Six- and 12-month Results

Results, at 6 and 12 months, for the intervention group vs. usual care compared to baseline

 

Intervention group

Usual care group

P value

Weight: 6 months

3.9 kg decrease

0.3 kg gain

< 0.001

Weight: 12 months

2.9 kg decrease

1.2 kg decrease

0.06 (NS)

Physical activity: 12 months

12 minute/day increase

No change

0.04

NS = not significant

The authors stressed the significant weight loss at six months in the intervention group, and they noted the plateau of weight loss in the latter six months as possibly because of the decrease in phone coaching interaction as the study progressed. They also provided a positive spin on the fact that the intervention group had less of a decrease in total exercise time, while modestly increasing moderate intensity exercise. Their conjuncture was that moderate-to-vigorous intensity exercise partially displaced the light intensity exercise, a positive switch to the type of exercise most convincing in the literature for health benefits.

COMMENTARY

It’s not easy to lose weight. As this trial found, even when weight loss initially occurs (and the intervention group lost a significant amount of weight at the six-month mark), the maintenance phase can be an additional challenge. At least the intervention in this study, a web- and phone-based approach, stabilized the weight loss, showing a non-significant change in weight over the second six months.

Sometimes, clinicians need to use whatever tools are available to help patients achieve their health goals. With integrative health, that might mean tapping into knowledge that’s been refined over thousands of years, such as with traditional Chinese medicine or Ayurvedic medicine. Alternatively, using technology, in this case a web-based, self-monitoring technique for weight loss and activity promotion, might be the “prescription” that someone needs. These technological approaches are permeating the marketplace, and clinical research, with some data, like this study, are promoting their positive effects. The lead researcher of this study since has been involved with numerous other eHealth initiatives in other demographics.1 Perhaps someday, the medical literature, mixed with clinical experience and patient preference, will be able to pinpoint the best combination of coaching and technology to help patients achieve their health goals.

This study is methodologically sound, with its randomized, prospective design convincing in tracing the outcomes back to the specific intervention studied. The small size of the control group (usual care) may have led to the weight loss findings (1.2 kg at 12 months, on par statistically with the intervention group) that may have disappeared with a larger sample size. Furthermore, hopefully the researchers will tackle the appropriateness and effectiveness of this approach on other demographics, cultural groups, and ethnicities, expanding beyond the “English speakers only” inclusion criteria. In our diverse society, as clinicians we need to know what works for everyone.

There is little reason not to bring this approach to our patients wishing, or needing, to increase their activity and/or achieve weight loss goals. In our clinics, we will want to have access to health coaches, and make sure that we are familiar with the websites and technology available, including costs, to our patients. If we are organized in these respects, our patients should be able to reach the weight loss and exercise targets realized in this study.

REFERENCE

  1. Van Blarigan EL, Kenfeield SA, Cadmus-Bertram LA, et al. The Fitbit One physical activity tracker in men with prostate cancer: Validation study. JMIR Cancer 2017;3(1):e5. doi: 10.2196/cancer.6935.