Look AHEAD Lifestyle Regimen Ups Quality of Life in Diabetes

Marlene Busko

June 22, 2016

NEW ORLEANS — Although overweight and obese patients with type 2 diabetes in the intensive lifestyle intervention arm in the Action for Health in Diabetes (Look AHEAD) trial did not have better cardiovascular outcomes (the primary end point) than their peers in the diabetes-education control arm, they maintained a modest but clinically meaningful weight loss for almost a decade. And importantly, this had a positive impact on quality of life, which was defined as including physical function, social function, and depression.

The patients were better able to perform daily tasks and had greater mobility and a better mood, Garth R Dutton, PhD, a clinical psychiatrist at the division of preventive medicine, University of Alabama at Birmingham, reported. He reviewed this secondary outcome from Look AHEAD in a symposium entitled "Beyond A1c—why quality of life matters" here at the American Diabetes Association (ADA) 2016 Scientific Sessions last week.

Clinicians need to know that "it's important to have the conversation" about quality of life with a diabetes patient, "even if you don't administer a validated questionnaire and get a score," he told Medscape Medical News at a press briefing before the symposium. Doctors can ask patients, "How is this affecting you? What are you no longer able to do that you used to be able to do? What bothers you about this?"

This will start a conversation that "will eventually improve clinical care, because then you have a better idea of what, besides the [HbA1c] numbers, the patient is struggling with," he said. In managing diabetes, "slow and steady wins the race," he added, so a modest, sustained weight loss is important. The patients in the trial's intensive-lifestyle intervention arm had significant improvements in measures such as "how well you get around, move up the stairs, and walk a city block," he emphasized.

Press briefing moderator Kimberley A Driscoll, PhD, assistant professor of pediatrics, University of Colorado, Denver School of Medicine, agrees.

"I hope that one day quality of life will be standard of care and part of the routine diabetes clinic visit, just like taking blood pressure, height, weight…[and] HbA1c," she stressed.

"Slow and Steady" Weight Loss Ups Quality of Life

As previously reported and published in 2013, Look AHEAD aimed to examine whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among overweight or obese patients with type 2 diabetes, Dr Dutton summarized.

In the study, 5145 middle-aged adults with type 2 diabetes who were 45 to 74 years old and were overweight or obese were randomized at 16 study centers in the United States to receive the study or control intervention. About 60% of the patients were women, and about 37% belonged to racial minorities.

The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina up to 13.5 years, but the trial was stopped after a median of 9.6 years, due to futility for this outcome.

Weight loss was greater in the intervention group than in the control group throughout the study (the intervention group lost 8.6% of their body weight compared with just 0.7% in the control at 1 year and 6.0% vs 3.5% at study end). Thus, "the intervention did what it was supposed to do" in terms of achieving weight loss, Dr Dutton said.

And the study intervention was quite intense, he noted. "In the first 6 months, they had weekly contact with an interventionalist — which focused on calorie reduction and physical activity, with lots of behavioral strategies, support, problem solving, and goal setting." In the second 6 months, the patients saw an interventionalist 3 times a month, and after year 1, they still had regular, monthly contact.

"So really in the first year, the intervention was an 'everything-but-the-kitchen-sink' approach, and that tapered over time," Dr Dutton summarized.

Among patients in the lifestyle-intervention group, physical function improved most at 1 year, after the most intense phase of the intervention, and although it declined over time, it remained better than in the control group.

Patients in the lifestyle-intervention group were also 15% less likely to have elevated depressive symptoms at 8 years.

The intensive-lifestyle intervention group also experienced a 48% lower risk of loss of mobility, with 12.3% of them having severe mobility-related disability after 1 year, compared with 18.9% in the control group. After 4 years, these figures were 20.6% vs 26.2%.

These results highlight that modest, sustained weight loss in overweight and obese patients with type 2 diabetes produces meaningful benefits, including mitigating deteriorations in physical function and quality of life that typically occur with aging, according to Dr Dutton.

"Many of the outcomes we measured, including physical functioning, mobility, and depressive symptoms, are very important to patients who are understandably interested in maximizing their quality of life and maintaining their independence for as long as possible," he concluded.

The Two Groups in Look AHEAD

Diabetes Support and Education (Control) Intervention in Look AHEAD

Participants had three group sessions a year focused on diet, exercise, and social support during years 1 through 4.

In subsequent years, they had one group session a year.

Intensive Lifestyle Intervention in Look AHEAD [3]

The intervention was designed to induce a mean loss ≥ 7% of initial weight and increase participants' moderately intense physical activity to ≥ 175 minutes a week.

First 6 months: Participants had one individual and three group sessions a month and were encouraged to replace two meals and one snack each day with liquid shakes or meal bars.

Months 7 to 12: Participants had one individual and two group meetings a month, and for the rest of the program they were encouraged to replace one meal a day with a shake or meal bar.

Starting at month 7: Participants could receive more intensive behavioral interventions and weight-loss medication.

Years 2 to 4: Participants had at least one on-site visit each month as well as a contact by phone, mail, or e-mail, and they could participate in a 6- to 8-week refresher group and three motivational campaigns a year.

After year 4: Participants were offered monthly individual visits, one refresher group, and one motivational campaign a year.

Dr Dutton and Dr Driscoll have no relevant financial relationships.

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American Diabetes Association 2016 Scientific Sessions; June 11, 2016; New Orleans, Louisiana. Presentation 2-BM-SY02

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