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Pounds Off With Empowerment (Power)
Pounds Off With Empowerment (Power) -- Posted by Gumbo on 10-31-04 05:10
Pounds Off With Empowerment (Power)
Originally Published:20041001.
Individuals who live in rural medically under served communities are an
important target population for translational research. Such research
evaluates interventions that are designed and implemented for various
population settings on the basis of efficacy established during previous
randomized controlled trials. In South Carolina, 75% of counties are
designated as "medically under served" by the US Public Health Service,1 and
the prevalence of overweight, obesity, and physician-diagnosed diabetes is
among the highest in the nation.2 Approximately 30% of the state population
is Black, and among Black adults who have type 2 diabetes, glucose control
as indicated by glycaled hemoglobin (HbA1c) has been shown to be
considerably higher than among White adults (10.5% vs 8.4%).3
Previous clinical trials have shown that among persons who have type 2
diabetes, moderate weight loss can improve glycemic control and lipoprotein
profile and reduce blood pressure.4-6 Although definitive data on the
benefits of long-term weight loss to reduce risk for clinical complications
of diabetes are not yet available, the evidence-based nutrition
recommendations of the American Diabetes Association emphasize the
importance of weight management as a key element of medical nutrition
therapy for diabetes. The American Diabetes Association also emphasizes the
importance of glycemic control and management of cardiovascular risk
factors, regardless of weight status.7
Among urban Black populations, including those who have diabetes, the
success of culturally sensitive behavioral weight loss programs has been
reported,5,8-12 although some studies reported that, compared with Whites,
Blacks lost less weight10 and had an increased tendency to regain weight.11
To date, only a limited number of studies of behavioral programs for persons
who have type 2 diabetes have been conducted in rural or semirural
communities, where improvements in glycemic control and weight loss
varied.13-16 The goal of our study was to develop, implement, and evaluate a
1-year primary care-based lifestyle intervention for weight management that
was designed to improve metabolic control among individuals who have type 2
diabetes and live in rural medically underserved communities. The
state-of-the art lifestyle intervention program developed for the National
Institutes of Health-funded Diabetes Prevention Program (DPP),17 in
combination with experiences gained from an 8-week pilot study13 and focus
groups, was used to guide the planning and the implementation of our
12-month randomized controlled trial ("intensive-lifestyle" intervention).
Because of the limited amount of time for health education that is normally
reimbursed by health insurance, we evaluated a second weight management
strategy. It was designed to deliver the most salient elements of the
intensive-lifestyle intervention within the approximate number of hours that
are usually reimbursed by Medicare for 12-month nutritional education among
persons who have recently been diagnosed with diabetes
("reimbursable-lifesyle" intervention).
METHODS
Setting
Our 12-month randomized clinical trial-POWER (Pounds Off With
Empowerment)-was a collaborative effort between the University of South
Carolina and the South Carolina Primary Health Care Association, which
represents the federally funded primary health care facilities in the state
that provide care to medically under served communities. Two primary health
care centers in rural counties were identified on the basis of large numbers
of patient visits for diabetes care.
Both health centers were provided with subcontracts that covered the costs
of implementing the study on-site, including funds for hiring study staff
and for providing transportation to study participants. Thus, the project
was highly visible and was integrated into the daily operations of the
health centers.
Participant Eligibility and Recruitment
A detailed description of the recruitment process has been published
elsewhere.18 Briefly, potentially eligible participants were identified
through diabetes registries at each health center. Inclusion criteria
included being aged 45 years or older and having had a clinical diagnosis of
diabetes. Potential participants also had to have a body mass index (BMI) of
25 kilogram/meter2 (kg/m2) or greater during the previous calendar year,
which was confirmed by a brief medical record review. Exclusion criteria
included any limitation that would prohibit full participation in the study
(e.g., metastatic cancer, multiple or recent [within 6 months] myocardial
infarction or stroke, dialysis for end-stage renal disease, severe
psychiatric disease or dementia, or inability to walk). An introductory
letter cosigned by the health center's medical director and the study's
principal investigator was sent to eligible potential study participants;
this was followed up with a recruitment and eligibility-screening phone
call. Those who were both eligible and interested in participating were
asked to complete 2 screening visits to further establish eligibility and
interest in the study. Eligible participants were required to complete a
3-day "run-in" program designed to confirm both interest in participation
and the minimal ability to self-monitor diet and physical activity. This was
followed by a third visit to collect baseline study measurements and to
assign participants randomly to 1 of 3 study interventions.
Of the 664 potential participants contacted by phone, 143 (21.5%) were
randomized into the study, which was similar to the recruitment yield in
university-based behavioral trials.19 Another 53 participants attended the
initial screening visit on the basis of response to local publication
efforts (posters, etc.), and 46 (87%) of these were randomized. Two of the
189 randomized participants were subsequently excluded because of severe
congestive heart failure; thus, 187 participants were included in the trial.
Intervention
All participants were given a study goal of achieving and maintaining a 10%
weight loss over 12 months on the basis of weight measured at randomization.
Participants were randomized into 1 of 3 interventions: intensive-lifestyle
intervention, reimbursable-lifestyle intervention, or usual care. The
intensive-lifestyle intervention was derived from the lifestyle intervention
of the DPP.17 The program focused on moderate weight loss with a goal of 25%
of calories from dietary fat and a minimum of 150 minutes of physical
activity per week that was similar in intensity to brisk walking. Energy
intake goals were added as necessary. The DPP intervention was delivered
primarily via individual counseling sessions, and key elements included
frequent, sustained contact with a trained interventionist; a structured
16-session core curriculum composed of behavioral strategies for weight loss
and physical activity, such as self-monitoring of diet and physical
activity; and additional behavioral strategies to assist with achieving
weight loss goals that were tailored to individual needs in a culturally
appropriate manner.
For our study, we made modifications to the DPP intervention on the basis of
an 8-week pilot study13 and findings from 2 focus groups. Modifications
included regular use of group sessions, considerable simplification and
reduction in the amount of written materials, encouragement of physical
activity at low to moderate intensity for individuals who had very sedentary
lifestyles, and inclusion of additional regionally/culturally appropriate
examples, such as modifications of regularly consumed foods (e.g.,
substitute turkey neck bone for ham bone to cook greens, low-fat seasoning
for grits) and suggestions for physical activity (e.g., identification of
safe places to walk in the community, use of chair exercises for individuals
who had lower-extremity pain). Self-monitoring tools for diet and physical
activity were retained in a very simple format. Information regarding
selected aspects of diabetes care (e.g., encouragement to monitor blood
glucose at home) was incorporated, although the intervention retained a
clear focus on diet and physical activity. Intensive-lifestyle participants
met weekly with the study nutritionist for delivery of the first 4 months of
the core curriculum (intensive), every other week for the next 2 months
(transition), and once a month for the remaining 6 months (maintenance).
Nutritionists delivered both the nutritional and the physical activity
components of the intervention within these scheduled 1-hour sessions.
Sessions were modeled after the NIH-funded Trial of Non-Pharmacologic
Interventions in the Elderly20 and were conducted sequentially in a pattern
of 3 group sessions and 1 individual session.
The reimbursable-lifestyle intervention was a condensed version of the
intensive-lifestyle intervention, in which key elements of the
intensive-lifestyle intervention were delivered in 4 1-hour sessions over
the course of the 12-month study and included 3 group sessions and 1
individual session. The total time allotted for delivery of this
intervention was determined by the approximate number of hours reimbursed
annually by Medicare for diabetes education (diet and physical activity) in
South Carolina for an individual who was recently diagnosed with diabetes.
Usual care was delivered in 1 individual session by a study nutritionist at
the beginning of the 12-month period. Information related to diet and
physical activity was derived from materials developed by the American
Diabetes Association and the American Dietetic Association.
Outcome Measures
Standardized measurement visits occurred during the randomization visit and
during visits scheduled at 3 months, 6 months, and 12 months after
randomization. The primary outcome was weight loss; weight was measured to
the nearest 0.23 kg (0.5 lb) with a Detecto balance beam scale that had a
Stadimeter (Cardinal Scale Manufacturing Company, Webb City, Mo). Height was
measured to the nearest 0.1 centimeter while the participants stood erect,
looking forward, against the stadimeter after taking a full inspiration. BMI
was calculated as kg/m2.
Secondary outcomes included HbA1c (marker of glycemic control), lipid
profile, and blood pressure. Laboratory assays of glycated hemoglobin, total
cholesterol, high-density lipoprotcin (HDL) cholesterol, triglycerides, and
low-density lipoprotein (LDL) cholesterol were conducted at the Analytic
Chemistry Laboratory of the South Carolina Department of Health and
Environmental Control with the Boehringer Mannheim (Hitachi 911 Analyzer;
Roche Diagnostics, Indianapolis, Ind). These assays were conducted during
the randomization and 6-month visits only.
Blood pressure was measured 3 times with a standard mercury sphygmomanometer
(appropriate cuff sizes-adult regular, large arm, or thigh-were used); the
averages of the second and third readings for systolic and diastolic
pressure were included in the statistical analysis.
Quality Control
Research staff participated in a 3-day centralized training and
certification process before the start of data collection; recertification
took place before the 6-month and 12-month measurement visits. Additionally,
the 2 nutritionists received training for the intervention protocols.
Following the training, weekly conference calls were held with the on-site
nutritionists and the university-based study research nutritionist to ensure
continual high-quality delivery of the intervention, with an emphasis on
appropriate responses to group or individual needs.
Statistical Analysis
Sample size was determined by the sample size formula for group
randomization proposed by Donner.21 The sample size (n=50 per group) allowed
detection at a=0.05 of a 6% weight loss at the end of the study, with 80%
power, for intensive-lifestyle intervention versus usual care and for
reimbursable-lifestyle intervention versus usual care.
Intervention effects were first evaluated with paired t tests within each
randomization group. Potential differences between intensive-lifestyle
intervention and usual care and between reimbursable-lifestyle intervention
and usual care were evaluated with linear regression modeling of weight
change that accounted for clinical site and for change in use of prescribed
diabetes medication (insulin, metformin, and other oral hypoglycemic agents)
during the course of the 1-year intervention period. Models did not require
adjustment for education, gender, or age because these did not differ
significantly between randomization groups at baseline. Additionally,
between-group differences were evaluated with random effects and
repeated-measures regression models in SAS PROC MIXED (SAS Institute Inc,
Cary, NC), with specification of random clinic effects within random subject
effects that allowed for missing values from follow-up visits. These results
were essentially the same as those from the simpler regression modeling;
therefore, the regression model results are presented in the results
section. Because of the skewed distribution of plasma triglyceride values,
analyses of triglycerides were conducted with a natural log transformation.
To eliminate the possibility of health center differences in intervention
delivery, we tested the interaction between clinic and randomization group,
and no such interactions were detected. Finally, analyses were repeated in
the subgroup of study participants ("high attendees") who attended at least
50% of the core curriculum and transitional sessions for intensive-lifestyle
intervention (n=36) or at least 2 of the 4 sessions for
reimbursable-lifestyle intervention (n=47).
RESULTS
Sample Characteristics
Of the 187 participants, 152 (81%) were retained through the 12-month
end-of-study measurement visit. Baseline characteristics of these 152
individuals are shown in Table 1 according to randomization assignment.
Overall, 80% of participants were women, 82% were Black, the average age was
60 years, and the average BMI was 36.7 kg/m2. Forty-eight percent of
participants had less than a high school education or equivalent, and the
average duration of diabetes was 11 years. None of the measured baseline
characteristics differed significantly among intervention groups at baseline
(all P>.05).
Primary Outcome
Figure 1 shows weight change at 3, 6, and 12 months post randomization for
usual care, intensive-lifestyle intervention, and reimbursable-lifestyle
intervention. Paired t tests within each group at 6 months showed
statistically significant weight loss between randomization and follow-up
among intensive-lifestyle participants (paired t test P<.0001) but not among
reimbursable-lifestyle or usual-care participants. The regression models
showed that weight change at 6 months was significantly greater among
intensive-lifestyle participants compared with usual-care participants
(P<.01). Although some regain of lost weight was observed at 12 months,
weight loss among intensive-lifestyle participants of 2.2 kg was
significantly different from baseline (paired t test P<.003). Weight loss
among men and women in the intensive-lifestyle group was comparable at 3 and
6 months (P>.05); however, at 12 months, mean weight loss among men was 4.7
kg compared with 1.5 kg among women (P=.02). Weight loss of 2.2 kg at 12
months among the intensive-lifestyle participants compared with 0.3 kg among
the usual-care participants (P=.055) did not differ according to gender
(P>.05). Weight loss did not differ significantly between
reimbursable-lifestyle and usual-care participants at either 6 months or 12
months post randomization.
To more fully understand patterns of weight change in this trial, 3
categories were defined arbitrarily as "gained 2 or more kg," "stable weight
(within 2 kg)," and "lost 2 or more kg"; results are shown in Figure 2 for
each group at 12-months post randomization. Forty-nine percent of the
intensive-lifestyle participants lost at least 2 kg compared with 25% of the
usual-care participants; conversely, 12% of the intensive-lifestyle
participants gained at least 2 kg compared with 27% of the usual-care
participants (from ?2 statistic, P<.05). Reimbursable-lifestyle participants
did not differ significantly from usual-care participants in these analyses.
Secondary Outcomes
Figure 3 shows the unexpected decline of HbA1c by 1.1 points among
usual-care participants (paired ( test P<.01), by 1.6 points among
intensive-lifestyle participants (paired t test P<.01), and by 0.8 points
among reimbursable-lifestyle participants (paired t test P<.05). On the
basis of regression analyses, differences in HbA1c change between the
intensive-lifestyle and usual-care participants and between
reimbursable-lifestyle and usual-care participants were not statistically
significant. This was true before and after consideration of prescribed
diabetes medications and weight change. Furthermore, neither diabetes
medication regimen nor weight change was predictive of change in HbA1c.
Although most of the secondary metabolic outcomes we evaluated improved
modestly among all 3 groups (Table 2), none of the 6-month differences in
these measures were significantly different between intensive-lifestyle and
usual-care participants or between reimbursable-lifestyle and usual-care
participants.
Analyses Restricted to "High Attenders"
Of the 49 individuals in the intensive-lifestyle intervention, 36 (73%)
attended at least 50% of the core curriculum and transition sessions, and
all 47 individuals in the reimbursable-lifestyle intervention attended at
least 2 of the 4 sessions; all usual-care participants were included for
comparison. Among the intensive-lifestyle "high attenders," mean weight loss
at 6 and 12 months was 3.1 kg (P<.001 compared with usual-care participants)
and 2.7 kg (P<.05 compared with usual-care participants), respectively.
DISCUSSION
The POWER study was conducted as a translational research project designed
to evaluate the effectiveness of a state-of-the-art lifestyle intervention
for weight management and metabolic control of diabetes. It was applied to
older adults, primarily Black, who had physician-diagnosed type 2 diabetes
and lived in rural medically under served communities in South Carolina.
Modest weight loss occurred at 6 months and was statistically significantly
greater among the intensive-lifestyle participants compared with the
usual-care participants. At 12 months, a significantly greater proportion of
intensive-lifestyle participants compared with usual-care participants had
lost at least 2 kg. No statistically significant weight loss was observed
among reimbursable-lifestyle participants. Men were less likely to regain
lost weight, although this result should be reviewed with considerable
caution because of the small number of men in the intensive-lifestyle group
(n=11). Differences between groups in lipid profile and blood pressure were
not statistically significant; however, glycemic control measured by HbA1c
improved among all 3 groups.
Weight Loss and Metabolic Status
Weight loss at 6 months among the intensive-lifestyle participants was
similar to results from a 6-month lifestyle intervention among older Black
adults who had diabetes and lived in an urban setting (average weight loss=
1.3 kg).5 More recently, the Steps to Soulful Living intervention (not
limited to individuals who had diabetes) resulted in a 3.7-kg weight loss at
6 months.22 Among the DPP cohort, average weight loss at 6 months post
randomization among the intensive-life-style participants was about 7 kg,
and at the end of the study, it was 5.6 kg.23 Differences in attained weight
loss between POWER and DPP could have been the result of longstanding
diabetes (and the attendant diabetes medications, many of which promote
weight gain) among POWER participants.24 It also could have been the result
of incomplete identification and response to a range of potential barriers
to weight loss or weight loss maintenance (see next section, Potential
Barriers to Health Action). That the reimbursable-lifestyle participants did
not lose weight is of concern because (1) the professional contact time
allotted was the maximum normally covered by Medicare in South Carolina for
patients recently diagnosed diabetes, and (2) less time is reimbursed for
patients who have established diabetes.
The potential relevance of the observed improvement in HbA1c among the
intensive-lifestyle participants (1.6%) is evident from controlled clinical
trials in which glycemic control was predictive of risk for microvascular
complications, including diabetic retinopathy and nephropathy.25,26
Additionally, prospective epidemiologic analyses have estimated that each 1%
reduction in HbA1c was associated with a 14% reduction in risk for
myocardial infarction and a 21% risk reduction for death related to
diabetes.27 Agurs-Collins et al.5 found that HbA1c was reduced from 11.0% to
9.9% among the weight loss intervention group compared with an increase of
10.0% to 11.5% among the control group (P<.05). Change in HbA1c was not
statistically attributable to weight loss and was presumed to have improved
as a result of improved diabetes self-management that may have occurred as
an indirect benefit of the intervention.
Among POWER participants, neither prescribed medication regimen nor weight
change was predictive of improved HbA1c. While the POWER trial was ongoing,
a "diabetes collaborative" was introduced into both of the clinic sites as
part of a federally funded effort to improve chronic disease management
among community health center patients. Thus, improvement in day-to-day
diabetes management, including consistency in taking prescribed diabetes
medication and monitoring blood glucose at home, may have accounted for the
improved glycemic control.28 Additionally, individuals who were willing to
participate in this 1-year clinical trial may have been inherently motivated
to make the needed day-to-day diabetes management changes. Certainly,
improvement in HbA1c among usual-care participants was a welcome finding,
but it likely precluded identification of a statistically significant
difference between usual-care and intensive-lifestyle participants.
With regard to lipid profile and blood pressure, improvements were modest
and, like the work of Agurs-Collins et al.,5 were generally nonsignificant.
Similarly, a 1-year trial of a culturally sensitive weight management
intervention among Black women (n=529 from 16 churches) demonstrated modest
but statistically significant weight loss differences (1.1 kg for
intervention vs 0.83 kg for control) but no statistically significant
difference between intervention and control for lipids or blood pressure.29
(Previous studies that demonstrated statistically significant improvement in
these parameters in the context of a weight loss intervention were conducted
either among persons who did not have diabetes,30 who had a greater amount
of weight loss,31 or both. Thus, given the modest weight loss among POWER
participants and the relatively small sample size, it was not surprising
that statistically significant improvements in lipid profile or blood
pressure were not detected. Wing et al.4 demonstrated a dose-response effect
of weight loss on these metabolic outcomes; therefore, it is reasonable to
assume that modest weight loss may confer some degree of health benefit.
Potential Barriers to Health Action
Factors that influenced day-to-day diabetes management among 70 Black women
were assessed via a series of 10 focus groups that included both urban- and
rural-dwelling women in North Carolina.32 Key themes included spirituality,
general life stress and multicaregiving duties, feelings of dietary
deprivation, physical and emotional "tiredness," "worry," and fear of
diabetes complications. These factors also were noted during the POWER trial
and were addressed to the extent possible during the intervention. For
example, stress related to responsibilities for the care of multiple family
members was noted as a common reason for missed intervention sessions. In
response, the POWER nutritionist contacted the participant and arranged for
make-up sessions via in-person or phone interactions. Attention to highly
specific participant needs, including transportation, played an important
role in achieving the overall retention rate of 81% and an attendance rate
of 73% among intensive-lifestyle participants who were present for at least
50% of the intensive and transitions sessions (i.e., at least 10 sessions).
CONCLUSIONS
Comprehensive intervention approaches that address documented barriers to
sustained behavior change for weight management and diabetes self-management
for individuals living in rural communities are needed. In particular, the
important barrier of payment for professional contact time and for
transportation to receive services must be addressed. With POWER, we have
documented that modest weight loss and improved glycemic control is
attainable by culturally appropriate state-of-the-art lifestyle
interventions among Black and White individuals who have type 2 diabetes and
live in rural medically under served communities. We also have shown that
the same intervention approach, when delivered in the amount of time
normally reimbursed by health insurance (i.e., 4-5 hours over 12 months),
was not effective in terms of weight loss; however, some improvement in
glycemic control was noted. For persons who have diabetes and live in rural
medically under served communities, future translational research should
focus on comprehensive approaches to diabetes management and education and
should be designed to elicit greater improvement in metabolic status and
health-related quality of life. Likely, focusing on medication compliance,
monitoring blood glucose at home, and other aspects of diabetes self-care
will be important. Additionally, future research should address the limited
numbers of health care providers in rural communities. Use of telemedicine
technology, including interactive video conferencing and Internet support,
should be considered. Future studies also should consider health insurance
and associated health policy and cost to ensure a means of delivering
services that arc effective in rural settings.
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