August/September 2020 Issue

Lifestyle Changes That Keep Pounds Off
By Hope Warshaw, MMSc, RD, CDE, BC-ADM, FADCES
Today’s Dietitian
Vol. 22, No. 7, P. 30

An Examination of the Clinical Trials That Have Spawned Successful Strategies for People With and Without Diabetes

Consumers are led to believe that the monumental challenge of weight control is shedding those unwanted pounds, and once they reach their ideal weight, keeping lost pounds off is a no-brainer. But research demonstrates the odds of weight regain—particularly if lifestyle changes aren’t made permanent—are high. Lessons on this topic are gleaned from pivotal studies, including those aimed at preventing or delaying prediabetes or type 2 diabetes.

This article shares topline details of these studies and distills the successful strategies for keeping lost pounds off. “It’s imperative that health care providers understand the phenomenon of weight regain,” says Colin Greaves, PhD, C Psychol, a professor of psychology applied to health at the University of Birmingham in the United Kingdom.

Health care providers must be more upfront with patients about what the research shows before they embark on their journey—perhaps not their first—down the scale. “Set a plan in motion for weight maintenance and engage people in increasing self-awareness when they embark on weight loss, not once they’ve lost the weight,” Greaves says.

Setting the Stage
More than 34 million people (10.5% of the US population) are estimated to have diabetes, with greater than 90% having type 2 diabetes.1 Twenty-seven percent of adults aged 65 and older have diabetes, and an estimated 88 million adults aged 18 and older (26% of the US population) have prediabetes.1,2

These upward trends track closely with overweight and obesity. Nearly 90% of US adults with diabetes had overweight or obesity.1 And roughly one-half of those with type 1 diabetes have overweight or obesity.3

Research Revelations
Pivotal studies conducted over the last two decades have attempted to crack the weight loss and maintenance code. Key details are provided here in chronological order.

National Weight Control Registry (NWCR)
Initiated: Began in 1994 and remains ongoing
Study type: Observational prospective investigation of weight loss maintenance
Study population: Adults who have lost at least 30 lbs and kept it off for at least one year
Question/goal: Identify successful weight maintainers and describe successful strategies longitudinally.
Details: Registry members complete self-reported annual surveys.
Findings: NWCR has published nearly 40 articles.4 Its 10-year study captures five predictors of weight loss maintenance success over 10 years in nearly 3,000 participants: 1) greater magnitude of initial weight loss and length of duration of maintenance, 2) maintenance of increased physical activity, 3) lower fat intake, 4) ability to practice restraint and low disinhibition around food (ability to manage oneself around food), and 5) self-weigh at least several times per week.

This study showed that continued adherence to all five behaviors improved long-term weight maintenance.4,5

Diabetes Prevention Program (DPP) and DPP Outcomes Study (DPPOS)
Initiated: DPP started in 1998 and stopped in 2001; DPPOS started in 2002 and still continues as an observational study.
Study type: Multisite National Institutes of Health (NIH)–funded randomized controlled trial (RCT)
Study population: 3,000 people at high risk of or with prediabetes
Question/goal: Can intensive lifestyle intervention delay onset of type 2 diabetes over time?
Details: Three study arms: 1) intensive lifestyle intervention, 2) metformin with standard care, and 3) placebo with standard care. Intensive lifestyle intervention goals: frequent individual counseling to achieve greater than 5% to 7% weight loss, healthful eating plan, and greater than 150 minutes of aerobic activity per week.
Findings: DPP: Intensive lifestyle intervention arm experienced greatest reduction in incidence of progressing to type 2 diabetes (58% compared with placebo). The more weight lost, the greater reduction in type 2 diabetes incidence. Weight loss was the dominant predictor. Physical activity helped sustain weight loss.

DPPOS: After 10 and 15 years of observation, the original intensive lifestyle intervention group compared with placebo reduced incidence of developing type 2 diabetes by 34% and 27%, respectively.5-7

POUNDS LOST (Preventing Overweight Using Novel Dietary Strategies)
Initiated: This two-year NIH-funded study started in 2004 and ended in 2007.
Study type: RCT at two study sites
Study population: 811 adults with overweight, 25 to 40 BMI
Question/goal: Was greater body weight change seen after two years on an eating plan characterized as low-fat vs high-fat and average-protein vs high-protein with low to high carbohydrate content?
Details: Subjects were randomized to four eating plans of varying macronutrient composition, ranging from 35% to 65% of calories from carbohydrate, and either 20% or 40% of calories from fat, and 15% to 25% of calories from protein. Participants were offered group and individual counseling.
Findings: No single nutrient composition fared better than the other. Subjects modified intake but didn’t reach the diets’ goals. Maximal weight loss was reached at six months with similar weight loss between various diets (7%/13 lbs), similar weight regain at 12 months, weight loss similar at two years (9 lbs), and subjects who attended two-thirds of counseling sessions lost more weight (20 lbs). Clinical improvements were seen in glycemia, insulin levels, lipids, and hypertension.8

Look AHEAD (Action for Health in Diabetes)
Initiated: Started in 2000 and ended in 2012
Study type: Multisite NIH-funded RCT
Study population: 5,137 adults with overweight or obesity diagnosed with type 2 diabetes who had the disease for three months to 13 years; median follow-up was 9.6 years.
Question/goal: Will intentional weight loss reduce the incidence of fatal and nonfatal cardiovascular and cerebrovascular events?
Details: Two study arms: 1) intensive lifestyle intervention and 2) standard diabetes support and education. Intensive lifestyle intervention goals: frequent individual counseling especially early to achieve greater than 7% weight loss at one year, 1,200 to 1,800 kcal per day with less than 30% of calories from fat, and greater than 175 minutes of physical activity per week.
Findings: Maximal weight loss in the intensive lifestyle intervention group was 8.6% compared with 0.7% in the control group. The intensive lifestyle intervention group regained weight in years two through four, but successfully kept 6% off by the end of the study. Subjects in the intensive lifestyle intervention group lost more than 10% of their weight and lowered incidence of fatal and nonfatal cardiovascular and cerebrovascular events by about 20%. Weight loss, not change in physical fitness, was the leading factor.9-11

DiRECT UK
Initiated: Began in 2014; the one-year intervention ended in 2017, and two-year follow-up ended in 2018.
Study type: Two-year open-label, cluster-randomized trial in 49 primary care provider practices in Scotland and England Study population: 306 adults (aged 20 to 65) with a BMI of 27 to 45 who were diagnosed with type 2 diabetes in the previous six years
Question/goal: Does greater than 33 lbs (15 kg) of weight loss cause remission of type 2 diabetes (see sidebar “What Is the Meaning of ‘Diabetes Remission’?” on page 34)
Details: Two study arms: 1) intervention group and 2) standard care. During year one (intervention year), study group discontinued glucose-lowering and blood pressure medications, consumed a total replacement low-energy formula for 12 to 20 weeks, then had stepped reintroduction of food over two to eight weeks; participants were provided with regular structured support for weight loss maintenance. Intervention year two consisted of monthly follow-up and support visits.
Findings: Among the intervention group, at one year, 46% experienced remission, 24% achieved greater than 33 lbs of weight loss, and subjects who lost 55 lbs experienced 86% remission. At one year after study conclusion (two years after initiation), 11% of subjects maintained greater than 33 lbs of weight loss, and 36% still were experiencing remission.12,13

The Successful Strategies
Lessons from these studies and many others have zeroed in on successful strategies for weight loss maintenance. The following are some of the most important takeaways:

• Individualize the approach. One size does not fit all—nor is there one right way. “Lifestyle programs used in the DPP/DPPOS and Look AHEAD studies work because they provide structure, in the calorie and fat gram goal, but flexibility to individualize an eating plan,” says Linda Delahanty, MS, RDN, LDN, director of nutrition and behavioral research at Massachusetts General Hospital Diabetes Center and a researcher on those studies.

Each person’s weight management journey is unique and his or her own. RDs can help support people as they live and learn by encouraging people to conduct mini-experiments to explore and fine-tune successful strategies and manage myriad food-related situations they encounter.

“From the outset, [we used] a steady focus on developing personal strategies for permanent behavioral change,” says Michael E. J. Lean, MD, DiRECT UK principal investigator.

• Recognize physiologic changes occur with weight loss. A growing body of research shows that people who’ve lost weight experience physiologic changes—weight loss changes metabolism permanently. RDs must acknowledge these changes and help clients develop approaches to compensate for them.

When weight loss occurs, the hormone ghrelin increases while the hormones leptin, amylin, and others decrease, leading to increased appetite. In addition, research shows that people who try to maintain a weight loss of 10% or more from their starting body weight generally will burn about 300 to 400 fewer calories based on their current lower body weight and body composition. This is due to a decrease in resting energy expenditure and an increased hunger response. These changes result in a greater preference for calorie-dense foods. All told, these physiologic changes work in opposition to maintaining a lower body weight. To be sure, grit and determination must be employed. Some experts are exploring the use of exogenous leptin and/or thyroid hormone to help manage these unhelpful hormonal changes.

• Master and sustain a positive psychological mindset and implement behavioral strategies. Several psychological factors increase weight loss maintenance. Patients who possess an internally driven or intrinsic motivation to achieve their goal is one factor.

Gary Foster, PhD, chief science officer of WW (formerly Weight Watchers), says, “Keep your ‘why’ close by. What’s in your head is just as important as what’s on your plate.”

Patients also should consider limiting internalized stigma about being overweight over their lifetime, minimizing novelty-seeking with food coupled with acquiring the skills to manage reduced disinhibition and restraint around food (physiologic changes). Lastly, they should practice and sustain new lifestyle behaviors until they become instinctual.

• Reduce and manage the tension between relapse and maintenance. RDs may find value in using the Conceptual Model of the Dynamics of Weight Loss Maintenance (see figure on page 33), developed by Greaves and colleagues in Europe. Use this model with clients for shared decision making or as a prompt for dialogue. The model portrays the chronic tension between relapse and maintenance. It emphasizes sources of tension as triggers for relapse and details strategies to reduce and manage this tension. Modifiers of tension, listed around the model, are reasons why relapses may occur (see sidebar “Case Study: A Weight Management Journey”).

Greaves recommends RDs focus on three strategies: 1) Encourage changes that minimize the tension. “Make changes that you can live with,” has become his team’s mantra; 2) Diffuse sources of tension. Ask, “How else might you address that need?; and 3) Address tension in context (when it’s at its strongest) to give people a sense of control over their eating behaviors.

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• Solidify a consistent and sufficient physical activity plan. There’s consensus that while physical activity has some benefits during weight loss, it has greater import for keeping pounds off.

“High levels of physical activity are the most critical factor in preventing weight regain. Few people are successful long term without making physical activity part of their life and lifestyle,” says James O. Hill, PhD, chair of the department of nutritional sciences at the University of Alabama Birmingham and codeveloper of the NWCR.

Physical activity is essential beyond burning calories. “It also optimizes metabolism, which counters some of the physiologic changes from weight loss that down-regulate metabolism, and helps regulate appetite,” Hill says. At least 60 minutes per day of planned physical exercise seems necessary, which can be a combination of aerobic and resistance training. Reducing sedentary behaviors, such as screen time, also helps.5

• Build new skills to eat and live more healthfully. RDs may take for granted that patients possess skills to shop, read labels, plan, and assemble meals. But they don’t necessarily. After assessing a person’s daily food choices, eating behaviors, lifestyle, and life schedule, consider doing a food and eating skills inventory.

Getting a sense of clients’ skills helps direct the skill-building work RDs will do. For some clients, this may simply mean showing them a handful of useful websites. For others, it may mean working with restaurant menus to zero in on more healthful choices or providing strategies to plan more time and cost-effective meals. “It’s not about will power,” Delahanty says. “It’s about lifestyle skill power.”

• Make food choices and develop eating habits that consistently work. Research shows a few changes made in eating behaviors can help prevent weight regain. One is eating breakfast. Whether it’s due to nutrition, physiology, or psychology, starting the day with a healthful breakfast helps with weight maintenance.

Another strategy? Keep it simple. For example, help patients come up with two to three palate-pleasing, easy-to-fix breakfasts and lunches. Suggest they eat these as often as possible to minimize decisions. Two studies show that meal replacements and formulas (eg, bars and beverages) in weight loss have value and give people a kick start to lose regained weight or get back on track.10,12 Again, it’s about simplicity, removing decision-making about food choices and portions.

Another successful strategy is for patients to minimize their focus on food, the variety of food, and preparation. In other words, clients don’t have to become culinary savants who explore foods, flavors, and preparation methods. Simplicity is key. “Counsel people to practice flexible restraint. Do not expect to eat perfectly every day,” Delahanty says.

• Create a relapse prevention plan. It’s important for patients to accept the notion that as life happens, relapses will occur. Use Greaves’ Conceptual Model (see figure on page 33) to show why relapses are a reality and that having a relapse prevention plan at the ready can be the antidote to weight regain.

Suggest clients determine their desirable weight range along with the weight at which they will implement their relapse prevention plan. Results from DiRECT UK found that one-half of subjects required a “rescue plan” and that relosing regained weight after an 11-lb regain was difficult.14 Therefore, reinforce the message that success is defined by how fast and well you get back on track. Frequent self-monitoring of weight also has been shown to be key in preventing weight regain.5,11

Takeaways for Dietitians
It’s essential that RDs reinforce with clients that hitting that desired number on the scale is only part of the journey. The other, forever journey is preventing weight regain. To achieve this goal, patients must stay actively engaged with support. It may be with an RD, individually or in a group, or in another supportive scenario. Long-term support is critical.

“Those of us helping people successfully achieve long-term weight loss maintenance need to help people transform their lives so that healthful eating and active living are linked to the most important things in their life,” Hill says.

Greaves encourages dietitians as they counsel people with overweight or obesity to remember that “helping people to help themselves is hard work!”

— Hope Warshaw, MMSc, RD, CDE, BC-ADM, FADCES, is owner of Hope Warshaw Associates, LLC, a diabetes- and nutrition-focused consultancy based in Asheville, North Carolina. She’s the author of numerous books published by the American Diabetes Association. Warshaw served as the 2016 president of the Association of Diabetes Care & Education Specialists and currently serves on the board of the Academy of Nutrition and Dietetics Foundation.

References
1. Centers for Disease Control and Prevention. National Diabetes Statistics Report 2020: estimates of diabetes and its burden in the United States. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf. Accessed June 2, 2020.

2. American Diabetes Association. 2. Classification and diagnosis of diabetes: Standards of Medical Care in Diabetes — 2020. Diabetes Care. 2019;43(Suppl 1):S14-S31.

3. Mottalib A, Kasetty M, Mar JY, Elseaidy T, Ashrafzadeh S, Hamdy O. Weight management in patients with type 1 diabetes and obesity. Curr Diab Rep. 2017;17(10):92.

4. National Weight Control Registry website. http://www.nwcr.ws/. Accessed June 2, 2020.

5. Knowler WC, Barrett-Connor E, Fowler SE, et al. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002;346(6):393-403.

6. Diabetes Prevention Program Research Group, Knowler WC, Fowler SE, et al. 10-year follow-up of diabetes incidence and weight loss in the Diabetes Prevention Program Outcomes Study. Lancet. 2009;374(9702):1677-1686.

7. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015;3(11):866-875.

8. Sacks FM, Bray GA, Carey VJ, et al. Comparison of weight-loss diets with different compositions of fat, protein, and carbohydrates. N Engl J Med. 2009;360(9):859-873.

9. Look AHEAD Research Group, Pi-Sunyer X, Blackburn G, et al. Reduction in weight and cardiovascular disease risk factors in individuals with type 2 diabetes: one-year results of the Look AHEAD trial. Diabetes Care. 2007;30(6):1374-1383.

10. Look AHEAD Research Group, Wing RR, Bolin P, et al. Cardiovascular effects of intensive lifestyle intervention in type 2 diabetes. N Engl J Med. 2013;369(2):145-154.

11. Look AHEAD Research Group. Eight-year weight losses with an intensive lifestyle intervention: the Look AHEAD study. Obesity (Silver Spring). 2014;22(1):5-13.

12. Lean MEJ, Leslie WS, Barnes AC, et al. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018;391(10120):541-551.

13. Lean MEJ, Leslie WS, Barnes AC, et al. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019;7(5):344-355.

14. Lean MEJ. Low-calorie diets in the management of type 2 diabetes mellitus. Nat Rev Endocrinol. 2019;15(5):251-252.