Dietary Intervention for Postpartum Weight Retention
(PADaWL Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tripler Army Medical Center
Disqualifiers: Obesity, Preterm delivery, Severe morbidity, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Pregnancy and delivery are major stressors on the female body and contribute significantly to permanent weight gain and associated morbidity in women. This can profoundly affect the ability of active duty (AD) women to advance in their career. The first 12 weeks postpartum are the time period during which the most significant weight loss occurs and is critical in achieving a healthy weight in the first year postpartum. Many factors contribute to effective weight loss in this period among which the most critical are diet, exercise, and sleep. Breast feeding and depression may also affect weight changes postpartum. Research has shown diet to likely be the most crucial of these factors.
The PADaWL study is designed as a randomized controlled trial to assess the effects of dietary intervention on weight and physical fitness versus routine postpartum care in the first year postpartum. Subjects will be primiparous AD women from any military service recruited in the obstetric clinic in the third trimester of pregnancy at Tripler Army Medical Center. Data will collected in an ambi-directional fashion with pre-pregnancy physical fitness data, demographic and pregnancy data collected at time of enrollment. Subjects will be randomized to receive intensive virtual sessions with a dietician vs routine postpartum care for the first 12 months postpartum. We will utilize a biometric device to monitor activity levels and sleep, web-based diaries to monitor breast feeding and diet, and validated questionnaires to evaluate depression as well as diet and sleep. Subjects will be monitored weekly for the first 12 weeks postpartum and will then be further evaluated at 6, 9 and 12 months postpartum.
Primary outcome is weight at 12weeks postpartum and whether subjects have achieved military standards. Secondary outcome will be weight at 12 months postpartum and whether subject has achieved weight and fitness standards. The study intends to collect large amounts of data, and we intend to analyze which factors may be contributing to weight retention postpartum.
This study should provide an accurate assessment of the effects of pregnancy on AD women. It should generate a clean and accurate dataset on which multiple follow-on studies can be performed and provide data for designing further intervention studies in postpartum women. The results of this study should also be able to assist in developing policy and guidance concerning AD women and pregnancy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on diet and exercise for postpartum weight loss.
What data supports the effectiveness of the treatment Counseling with goal of modifying eating behaviors, Dietary Counseling, Nutritional Counseling, Behavioral Therapy for Eating Behaviors?
Research shows that patient-centered counseling and cognitive-behavioral therapy (CBT) are effective in helping people stick to healthy eating plans and change their eating habits. These approaches have been successful in managing weight and improving health in conditions like type 2 diabetes, suggesting they could also help with postpartum weight retention.
12345Is nutritional counseling safe for humans?
Nutritional counseling, often combined with cognitive-behavioral therapy, is generally safe and has been used effectively to help modify dietary habits and manage weight in various conditions, including postpartum weight retention and eating disorders.
23678How does the treatment of dietary counseling for postpartum weight retention differ from other treatments?
Dietary counseling for postpartum weight retention is unique because it focuses on modifying eating behaviors through personalized nutritional advice, often using approaches like the DASH diet, which is designed for gradual and healthy weight loss. Unlike other treatments that may involve medication or more generalized advice, this approach is tailored to individual needs and emphasizes adherence to a healthy dietary pattern.
69101112Eligibility Criteria
This trial is for active duty women from any military service who are experiencing their first pregnancy, have a BMI under 30 in the first trimester, and plan to remain on active duty for at least 18 months post-delivery. They must not be planning another pregnancy within that time and should stay on Oahu for at least 12 months after giving birth.Inclusion Criteria
Not planning short interval pregnancy within 18 months of delivery
Active Duty from any service - Army, Navy, Air Force, Marine, Coast Guard
Any type of delivery (spontaneous vaginal delivery, operative vaginal delivery, cesarean delivery)
+9 more
Exclusion Criteria
My newborn was in the NICU for more than 2 weeks.
No physical fitness test for record in the year prior to pregnancy
Delivery before 36 weeks
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Enrollment
Eligible participants meet with the research team, provide consent, and are randomized into study groups
1 week
1 visit (in-person)
Treatment
Participants receive dietary intervention and monitoring of diet, exercise, and sleep for the first 12 months postpartum
12 months
Weekly virtual sessions for the first 12 weeks, then at 6, 9, and 12 months
Intensive Data Collection
Intensive data collection on diet, activity, and sleep using biometric devices and web-based diaries
12 weeks
Weekly data submission
Follow-up
Participants are monitored for weight and fitness outcomes at 6, 9, and 12 months postpartum
12 months
3 visits (virtual)
Participant Groups
The study tests if counseling with a dietician can help new mothers return to pre-pregnancy weight and meet military fitness standards faster than usual care. Participants will get weekly virtual sessions with a dietician for the first year postpartum, alongside monitoring of activity levels, sleep, breastfeeding habits, diet, and depression.
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Arm 2Experimental Treatment1 Intervention
Women in this arm will not have dietary counseling but will have close supervision of diet, exercise and sleep.
Group II: Intervention Arm 1Experimental Treatment1 Intervention
Women in this arm will undergone dietary counseling in the first year postpartum in addition to close supervision of diet, exercise, and sleep.
Group III: ControlActive Control1 Intervention
Women in this arm will undergo routine postpartum care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Desmond Doss Health ClinicSchofield Barracks, HI
Tripler Army Medical CenterHonolulu, HI
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Who Is Running the Clinical Trial?
Tripler Army Medical CenterLead Sponsor
References
Facilitating dietary change: the patient-centered counseling model. [2022]Recent data indicate that the patient-centered counseling model enhances long-term dietary adherence. This model facilitates change by assessing patient needs and subsequently tailoring the intervention to the patient's stage in the process of change, personal goals, and unique challenges. This article describes this model, including its theoretical foundations, a 4-step counseling process, and applications. This behavioral counseling model can help nutrition professionals enhance patient adherence to nutrition care plans and dietary guidelines.
State of the evidence regarding behavior change theories and strategies in nutrition counseling to facilitate health and food behavior change. [2022]Behavior change theories and models, validated within the field of dietetics, offer systematic explanations for nutrition-related behavior change. They are integral to the nutrition care process, guiding nutrition assessment, intervention, and outcome evaluation. The American Dietetic Association Evidence Analysis Library Nutrition Counseling Workgroup conducted a systematic review of peer-reviewed literature related to behavior change theories and strategies used in nutrition counseling. Two hundred fourteen articles were reviewed between July 2007 and March 2008, and 87 studies met the inclusion criteria. The workgroup systematically evaluated these articles and formulated conclusion statements and grades based upon the available evidence. Strong evidence exists to support the use of a combination of behavioral theory and cognitive behavioral theory, the foundation for cognitive behavioral therapy (CBT), in facilitating modification of targeted dietary habits, weight, and cardiovascular and diabetes risk factors. Evidence is particularly strong in patients with type 2 diabetes receiving intensive, intermediate-duration (6 to 12 months) CBT, and long-term (>12 months duration) CBT targeting prevention or delay in onset of type 2 diabetes and hypertension. Few studies have assessed the application of the transtheoretical model on nutrition-related behavior change. Little research was available documenting the effectiveness of nutrition counseling utilizing social cognitive theory. Motivational interviewing was shown to be a highly effective counseling strategy, particularly when combined with CBT. Strong evidence substantiates the effectiveness of self-monitoring and meal replacements and/or structured meal plans. Compelling evidence exists to demonstrate that financial reward strategies are not effective. Goal setting, problem solving, and social support are effective strategies, but additional research is needed in more diverse populations. Routine documentation and evaluation of the effectiveness of behavior change theories and models applied to nutrition care interventions are recommended.
Cognitive-behavioral therapy and nutritional counseling in the treatment of bulimia nervosa and binge eating. [2019]The goals of manual-based cognitive-behavioral therapy (CBT) and nutritional counseling for eating disorders are similar, namely, eliminating dysfunctional patterns of eating. Modifying these behaviors requires specific therapeutic expertise in the principles and procedures of behavior change that is not typically part of the training of nutritionists and dieticians or mental health professionals without specific expertise. We discuss ways in which principles of behavior change can be applied to eating disorders by non-CBT experts. Specific nutritional rehabilitation programs have the potential to augment CBT in addressing the array of appetitive abnormalities present in eating disorder patients. The dysfunctional appetitive, hedonic, and metabolic characteristics of patients with bulimia nervosa (BN) and binge eating disorder are reviewed. These abnormalities constitute potential target areas that might be more fully addressed by nutritional interventions designed to restore normal appetitive function.
[Strategies in practical nutrition counseling]. [2009]The primary goal nutritional advice is to change the eating behaviour of the patients to diminish or abolish the nutrition related risks. Personal conversations define and analyse the problem for specific patient advice. This information should help to change the eating behaviour of the patients and to solve the primary nutritional problem. Follow-up appointments supervise the given advice and support the patients until the nutritional problem is solved. For several nutrition-related diseases the advice is best given in interactive group sessions (group therapy).
[Importance of nutritional counseling and dietary fiber content on glycemic control in type 2 diabetic patients under intensive educational intervention]. [2019]To evaluate the importance of nutritional counseling within a set of multidisciplinary interventions.
A pilot intervention to reduce postpartum weight retention at primary health care in Brazil. [2022]Background: postpartum weight retention (PWR) strongly predicts obesity, the major nutritional concern of this century; however, there is a gap in nutritional care for postpartum women in Brazil. Objective: to evaluate the effect of nutritional counselling provided at primary health care on the reduction of PWR. Method: pilot study carried out in a low-income community in southeastern Brazil, involving postpartum women with PWR, who were provided with individual monthly appointments with a nutritionist over three months of follow-up. Nutritional counselling was based on the Dietary Approach to Stop Hypertension (DASH diet) aiming at healthy and gradual weight loss. Anthropometric evaluation included measurement of weight, height, waist circumference and percentage of body fat. Dietary intake was assessed using a food frequency questionnaire and adherence to diet was evaluated using a DASH score. Results: women who participated in the study (n = 26) showed a reduction in PWR (median -1.80 kg, p = 0.004), body mass index (-0.57 kg/m², p = 0.004), and waist circumference (-2.50 cm, p = 0.024), as well as 91.67% of them presented good adherence to diet. Conclusion: nutritional counselling provided to low-income postpartum women at primary health care contributed to the reduction of PWR, body mass index and waist circumference, as the study participants presented good adherence to a healthy dietary pattern.
Effects of behavioral and pharmacological weight loss programs on nutrient intake. [2018]Behavior therapy is a widely used method for short-term weight control. Formal nutrition counseling is not included in many behavioral programs. To determine what types of diets were self-selected by patients and to see how they compared with individuals participating in a relaxation group with anorectic medication, the eating diaries compiled by participants in such a program were analyzed for 20 different nutrients. In general, pretreatment intakes were nutritious and typical for Americans. Both the behavioral and a relaxation-medication treatment produced weight loss and reduction in calorie intake. Both treatments were associated with the consumption of a fairly nutritious diet not much different from the pretreatment intake except for a reduction in the amount eaten.
Cognitive-behavioral approaches in the management of obesity. [2018]Many of the behavioral interventions designed to promote dietary change in individuals include medical assessment, initial assessment of diet history, assessing readiness, establishing dietary goals, self-monitoring, stimulus control training, training in problem solving, relapse prevention training, enlisting social support, nutrition education, dietary therapy, and ongoing contact to maintain progress. The comprehensive nature of a cognitive-behavioral weight management program is of value in modifying behaviors that are linked to adverse health effects and psychological distresses, without necessarily causing a drastic weight loss in obese individuals. The behavioral treatments for overweight and obesity directly modify behaviors that bear on health and illness, such as improving dietary choices, decreasing sedentary behaviors, and increasing habitual physical activity and exercises. Cognitive-behavioral treatment can be used to help overweight adolescents become more assertive in coping with the adverse social stigma of being overweight, enhance their self-esteem, and reduce their dissatisfaction with body image regardless of their weight loss. Cognitive-behavioral treatments seem to be more effective in children when delivered before puberty than they are for adults.
Effect of the e-health supported INTER-ACT lifestyle intervention on postpartum weight retention and body composition, and associations with lifestyle behavior: A randomized controlled trial. [2022]We investigated whether a postpartum lifestyle intervention reduced postpartum weight retention (PPWR) and improved body composition, and whether improved lifestyle was associated with less PPWR and improved body composition. A total of 1075 women with excessive gestational weight gain were randomized into the intervention (N = 551) or control (N = 524) group. A completion rate of 76% was reached. Anthropometrics and lifestyle data were collected at 6 weeks and 6 months postpartum. The e-health supported intervention consisted of 4 face-to-face coaching's, focusing on nutrition, exercise and mental wellbeing and using motivational interviewing and behavior change techniques. In the intervention group we observed; larger decrease in weight in women who reduced their energy intake (mean ± SD: 3.1 ± 4.2 kg vs. 2.2 ± 3.8 kg, P = 0.05) and decreased uncontrolled eating (3.5 ± 4.2 kg vs. 1.9 ± 3.7 kg, P ≤0.001) by the end of the intervention; larger decrease in fat percentage in women who reduced energy intake (2.3% ± 2.9 vs. 1.4% ± 2.7, P = 0.01), enhanced restrained eating (2.2% ± 3 vs. 1.4% ± 2.6, P = 0.02) and decreased uncontrolled eating (2.3% ± 2.9 vs. 1.5% ± 2.7, P = 0.01) and larger decrease in waist circumference in women who reduced energy intake (4.6 cm ± 4.8 vs. 3.3 cm ± 4.7, P = 0.01), enhanced restrained eating (4.5 cm ± 4.8 vs. 3.4 cm ± 4.8, P = 0.05) and decreased uncontrolled eating (4.7 cm ± 4.8 vs. 3.3 cm ± 4.8, P = 0.006), compared to those who did not. Improved energy intake, restrained eating and uncontrolled eating behavior were associated with more favorable outcomes in weight and body composition. ClinicalTrials.gov identifier:NCT02989142.
A Stepwise Approach to Prescribe Dietary Advice for Weight Management in Postpartum and Midlife Women. [2023]Weight retention and weight gain during the postpartum and midlife period subsequently increase the risk of chronic health conditions, thereby deteriorating the overall health. Dietary intervention is the pivotal component of sustainable weight management. However, in resource restricted settings, where dietitians may not be present, other healthcare professionals such as physicians, obstetricians, and paediatricians should play a vital role in providing timely weight management advice to these women. Therefore, this article provides dietary advice including the setting of realistic weight loss goals, identifying an individual's calorie needs, distribution of macronutrients and consideration of important micronutrients. Healthcare professionals can follow the stepwise approach to prescribe dietary advice to postpartum and midlife women for their weight management. Various dietary principles such as cultural and regional preferences of an individual, portion size, hypocaloric diets, nutrient-dense meals, eating habits, cultural beliefs and myths along with co-morbid conditions should be taken into consideration by healthcare professionals while providing the dietary prescription.
Effects of a lifestyle intervention on postpartum weight retention among women with elevated weight. [2022]The effectiveness of a pregnancy and postpartum behavioral lifestyle intervention on postpartum weight retention was examined.
Diets and eating disorders: implications for the breastfeeding mother. [2015]Although research is inconclusive or lacking, breastfeeding women who are on special diets or who have eating disorders are in need of nutritional counseling. This article provides information about the dietary risks of breastfeeding women, particularly those on weight-loss diets and vegetarian diets, and breastfeeding women who have anorexia or bulimia. Recommendations for dietary guidance are given based on information available about breastfeeding and maternal nutrition. Additional research is needed to determine the effect of the lactating woman's nutrition on her health and the health of her child.